-
The Ministry of Health, Labour andWelfare Ministerial
Notification No. 65
Pursuant to Paragraph 1, Article 41 of the Pharmaceutical
Affairs Law (Law No.145, 1960), the Japanese Pharmacopoeia
(hereinafter referred to as ``new Phar-macopoeia''), which has been
established as follows*, shall be applied on April 1,2011. However,
in the case of drugs which are listed in the Pharmacopoeia
(herein-after referred to as ``previous Pharmacopoeia'') [limited
to those listed in theJapanese Pharmacopoeia whose standards are
changed in accordance with thisnotification (hereinafter referred
to as ``new Pharmacopoeia'')] and drugs whichhave been approved as
of April 1, 2011 as prescribed under Paragraph 1, Article 14 ofthe
same law [including drugs the Minister of Health, Labour and
Welfare specifies(the Ministry of Health and Welfare Ministerial
Notification No. 104, 1994) as thoseexempted from marketing
approval pursuant to Paragraph 1, Article 14 of thePharmaceutical
Affairs Law (hereinafter referred to as ``drugs exempted
fromapproval'')], the Name and Standards established in the
previous Pharmacopoeia(limited to part of the Name and Standards
for the drugs concerned) may be acceptedto conform to the Name and
Standards established in the new Pharmacopoeia beforeand on
September 30, 2012. In the case of drugs which are listed in the
new Phar-macopoeia (excluding those listed in the previous
Pharmacopoeia) and drugs whichhave been approved as of April 1,
2011 as prescribed under Paragraph 1, Article 14 ofthe same law
(including those exempted from approval), they may be accepted
asthose being not listed in the new Pharmacopoeia before and on
September 30, 2012.
Ritsuo HosokawaThe Minister of Health, Labour and Welfare
March 24, 2011
(The text referred to by the term ``as follows'' are omitted
here. All of them are madeavailable for public exhibition at the
Evaluation and Licensing Division, Pharmaceu-tical and Food Safety
Bureau, Ministry of Health, Labour and Welfare, at eachRegional
Bureau of Health and Welfare, and at each Prefectural Office in
Japan).
*The term ``as follows'' here indicates the contents of the
Japanese Pharmacopoeia Sixteenth Editionfrom General Notices to
Ultraviolet-visible Reference Spectra (pp. 1 2131).
-
CONTENTS
Preface............................................................iThe
Japanese Pharmacopoeia, Sixteenth Edition .....1
General Notices
.............................................1
General Rules for Crude Drugs.........................5
General Rules for Preparations.........................7
General Tests, Processes and Apparatus............251. Chemical
Methods1.01 Alcohol Number Determination ..............251.02
Ammonium Limit Test .........................271.03 Chloride Limit
Test..............................281.04 Flame Coloration Test
..........................281.05 Mineral Oil Test
..................................281.06 Oxygen Flask Combustion
Method..........281.07 Heavy Metals Limit Test
.......................291.08 Nitrogen Determination
(Semimicro-
Kjeldahl Method)..............................301.09 Qualitative
Tests..................................311.10 Iron Limit Test
...................................371.11 Arsenic Limit Test
...............................371.12 Methanol
Test.....................................391.13 Fats and Fatty Oils
Test ........................391.14 Sulfate Limit Test
................................411.15 Readily Carbonizable
Substances Test ......412. Physical Methods
Chromatography2.01 Liquid
Chromatography........................422.02 Gas Chromatography
...........................452.03 Thin-layer Chromatography
...................472.04 Amino Acid Analysis of Proteins
............47
Spectroscopic Methods2.21 Nuclear Magnetic Resonance
Spectroscopy....................................482.22
Fluorometry .......................................502.23 Atomic
Absorption
Spectrophotometry............................512.24
Ultraviolet-visible Spectrophotometry.......522.25 Infrared
Spectrophotometry ...................53
Other Physical Methods2.41 Loss on Drying Test
.............................552.42 Congealing Point Determination
.............552.43 Loss on Ignition
Test............................562.44 Residue on Ignition Test
.......................562.45 Refractive Index Determination
..............562.46 Residual Solvents Test
..........................572.47 Osmolarity Determination
.....................572.48 Water Determination (Karl Fischer
Method)..........................................582.49 Optical
Rotation Determination ..............612.50 Endpoint Detection
Methods in
Titrimetry .......................................622.51
Conductivity Measurement ....................632.52 Thermal
Analysis.................................652.53 Viscosity
Determination ........................672.54 pH
Determination................................692.55 Vitamin A Assay
.................................712.56 Determination of Specific
Gravity and
Density ...........................................722.57
Boiling Point and Distilling Range
Test ...............................................742.58 X-Ray
Powder Diffraction Method .........752.59 Test for Total Organic
Carbon ...............792.60 Melting Point
Determination..................803. Powder Property
Determinations3.01 Determination of Bulk and Tapped
Densities .........................................823.02
Specific Surface Area by Gas
Adsorption......................................843.03 Powder
Particle Density
Determination ..................................863.04 Particle
Size Determination....................874. Biological
Tests/Biochemical Tests/
Microbial Tests4.01 Bacterial Endotoxins Test
......................924.02 Microbial Assay for Antibiotics
..............964.03 Digestion Test
...................................1004.04 Pyrogen Test
.....................................1034.05 Microbial Limit Test
...........................1034.06 Sterility
Test......................................1145. Tests for Crude
Drugs5.01 Crude Drugs Test ...............................1175.02
Microbial Limit Test for Crude Drugs ....1206. Tests for
Preparations6.01 Test for Metal Particles in Ophthalmic
Ointments......................................1266.02
Uniformity of Dosage Units .................1276.03 Particle Size
Distribution Test for
Preparations...................................1296.04 Test for
Acid-neutralizing Capacity of
Gastrointestinal Medicines.................1296.05 Test for
Extractable Volume of
Parenteral Preparations ....................1306.06 Foreign
Insoluble Matter Test for
Injections ......................................1316.07
Insoluble Particulate Matter Test for
Injections ......................................1316.08
Insoluble Particulate Matter Test for
Ophthalmic Solutions.......................1346.09
Disintegration Test .............................1356.10
Dissolution Test .................................137
-
JP XVIContents
6.11 Foreign Insoluble Matter Test forOphthalmic
Solutions.......................141
7. Tests for Containers and Packing Materials7.01 Test for Glass
Containers for Injections..1417.02 Test Methods for Plastic
Containers.......1427.03 Test for Rubber Closure for Aqueous
Infusions .......................................1488. Other
Methods8.01 Sterilization and Aseptic Manipulation ...1499.
Reference Standards; Standard Solutions;
Reagents, Test Solutions; MeasuringInstruments, Appliances,
etc.
Reference Standards9.01 Reference Standards
...........................150
Standard Solutions9.21 Standard Solutions for Volumetric
Analysis ........................................1539.22
Standard Solutions .............................1649.23 Matching
Fluids for Color ...................166
Reagents, Test Solutions, etc.9.41 Reagents, Test Solutions
......................1679.42 Solid Supports/Column Packings
for
Chromatography .............................3069.43 Filter
Papers, Filters for filtration,
Test Papers, Crucibles, etc. ...............3089.44 Standard
Particles, etc.........................308
Measuring Instruments and Appliances,Thermometers, etc.
9.61 Optical Filters for Wavelength andTransmission Rate
Calibration ...........309
9.62 Measuring Instruments, Appliances........3099.63
Thermometers ...................................310
Official Monographs
......................................313Crude Drugs
............................................1593
Infrared Reference Spectra .....................17751961
Ultraviolet-visible Reference Spectra .........19652131
General InformationG1 Physics and Chemistry
Guideline for Residual Solvents and Modelsfor the Residual
Solvents Test................2135
Inductively Coupled Plasma Atomic EmissionSpectrometry
......................................2136
Near Infrared Spectrometry......................2141pH Test for
Gastrointestinal Medicine ........2144System
Suitability...................................2145Test for Trace
Amounts of Aluminum in
Trans Parenteral Nutrition (TPN)Solutions
...........................................2146
Validation of Analytical Procedures ...........2148G2
Solid-state Properties
Laser Diffraction Measurement of
Particle Size .......................................2151Powder
Fineness ....................................2154Powder
Flow.........................................2155Solid and Particle
Densities ......................2158
G3 Biotechnological/Biological ProductsAmino Acid Analysis
..............................2159Basic Requirements for Viral
Safety of
Biotechnological/Biological Productslisted in Japanese
Pharmacopoeia ...........2166
Capillary Electrophoresis
.........................2179Isoelectric Focusing
................................2184Mass Spectrometry of Peptides
and
Proteins
............................................2186Mycoplasma Testing
for Cell Substrates used
for the Production of Biotechnological/Biological
Products..............................2188
Peptide
Mapping....................................2191Qualification of
Animals as Origin of
Animal-derived Medicinal Productsprovided in the General Notices
ofJapanese Pharmacopoeia and OtherStandards
..........................................2194
SDS-Polyacrylamide Gel Electrophoresis .....2196Total Protein
Assay ................................2201
G4 MicroorganismsDecision of Limit for Bacterial
Endotoxins
........................................2205Disinfection and
Sterilization Methods........2205Media Fill Test (Process
Simulation) ..........2206Microbial Attributes of Non-sterile
Pharmaceutical Products
......................2209Microbiological Evaluation of
Processing
Areas for Sterile
PharmaceuticalProducts............................................2211
Preservatives-Effectiveness Tests................2215Rapid
Counting of Microbes using
Fluorescent Staining.............................2217Rapid
Identification of Microorganisms
Based on Molecular Biological Method ....2220Sterility Assurance
for Terminally Sterilized
Pharmaceutical Products ......................2221Terminal
Sterilization and Sterilization
Indicators ..........................................2225G5
Crude Drugs
Aristolochic Acid ...................................2227Purity
Tests on Crude Drugs Using Genetic
Information .......................................2228On the
Scientific Names of Crude Drugs
Listed in the JP ..................................2231G6 Drug
Formulation
Tablet Friability Test ..............................2244G7
Containers and Package
Plastic Containers for Pharmaceutical
-
JP XVI Contents
Products............................................2244G8
Water
Quality Control of Water for PharmaceuticalUse
..................................................2246
Water to be used in the Tests of Drugs .......2253G9 Others
International Harmonization Implementedin the Japanese
Pharmacopoeia
SixteenthEdition..............................................2253
AppendixAtomic Weight Table (2010)
...........................2287Standard Atomic Weights 2010
.......................2288
Index
.........................................................2291Index
in Latin name .....................................2307Index in
Japanese.........................................2309
-
ii
PREFACE
The 15th Edition of the Japanese Pharmacopoeia(JP) was
promulgated by Ministerial Notification No.285 of the Ministry of
Health, Labour and Welfare(MHLW) on March 31, 2006.
In July 2006, the Committee on JP established thebasic
principles for the preparation of the JP 16th Edi-tion, setting out
the roles and characteristics of the JP,the definite measures for
the revision, and the date ofthe revision.
At the Committee, the five basic principles of JP,which we refer
to as the ``five pillars'', were estab-lished as follows: 1)
Including all drugs which are im-portant from the viewpoint of
health care and medicaltreatment; 2) Making qualitative improvement
by in-troducing the latest science and technology; 3) Pro-moting
internationalization; 4) Making prompt partialrevision as necessary
and facilitating smooth adminis-trative operation; and 5) Ensuring
transparencyregarding the revision, and disseminating the JP to
thepublic. It was agreed that the Committee on JP shouldmake
efforts, on the basis of these principles, to en-sure that the JP
is used more effectively in the fields ofhealth care and medical
treatment by taking appropri-ate measurements, including getting
the understandingand cooperation of other parties concerned.
It was agreed that the JP should provide an officialstandard,
being required to assure the quality of medi-cines in Japan in
response to the progress of scienceand technology and medical
demands at the time. Itshould define the standards for
specifications, as wellas the methods of testing to assure overall
quality ofall drugs in principle, and it should have a role
inclarifying the criteria for quality assurance of drugsthat are
recognized to be essential for public healthand medical
treatment.
The JP has been prepared with the aid of theknowledge and
experience of many professionals inthe pharmaceutical field.
Therefore, the JP shouldhave the characteristics of an official
standard, whichmight be widely used by all parties concerned.
Itshould provide information and understanding aboutthe quality of
drugs to the public, and it should beconducive to smooth and
effective regulatory controlof the quality of drugs, as well as
promoting andmaintaining international consistency and
harmoniza-tion of technical requirements.
It was also agreed that JP articles should cover
drugs, which are important from the viewpoint ofhealth care and
medical treatment, clinical results andfrequency of use, as soon as
possible after they reachthe market.
The target date for the publication of JP 16th Edi-tion (the
Japanese edition) was set as April 2011.
JP Expert Committees are organized with the fol-lowing panels:
Panel on the Principles of Revisions;Sub-committee on the
Principles of Revisions; Panelon Medicinal Chemicals; Panel on
Antibiotics; Panelon Biologicals; Panel on Crude Drugs; Panel on
Phar-maceutical Excipients; Panel on Physico-ChemicalMethods; Panel
on Preparations; Panel on PhysicalMethods; Panel on Biological
Tests; Panel on Nomen-clature; Panel on International
Harmonization; Panelon Pharmaceutical Water; and Panel on
ReferenceStandards. Furthermore, working groups are estab-lished
under the Panel on Physico-Chemical Methods,Panel on Preparations
and Panel on Biological Teststo expedite discussion on revision
drafts.
In the Committee on JP, Takao Hayakawa took therole of chairman
from July 2003 to December 2010,and Mitsuru Hashida from January
2011 to March2011.
In addition to the regular revision every five years inline with
the basic principles for the preparation of theJP it was agreed
that partial revision should be done asnecessary to take account of
recent progress of scienceand in the interests of international
harmonization.
In accordance with the above principles, the panelsinitiated
deliberations on selection of articles, and onrevisions for General
Notices, General Rules for CrudeDrugs, General Rules for
Preparations, General Tests,Monographs and so on.
Draft revisions covering subjects in General Notices,General
Rules for Crude Drugs, General Rules forPreparations, General Tests
and Monographs, forwhich discussions were finished between
September2005 and March 2007, were prepared for a supplementto the
JP 15. They were examined by the Committeeon JP in April 2007,
followed by the PharmaceuticalAffairs and Food Sanitation Council
(PAFSC) in June2007, and then submitted to the Minister of
Health,Labour and Welfare. The supplement was named``Supplement I
to the JP 15th Edition'', promulgatedon September 28, 2007 by
Ministerial Notification No.316 of MHLW, and became effective on
October 1,
-
iiii JP XVIPreface
2007.Numbers of discussions in the panels to prepare the
supplement drafts were as follows: Panel on Principlesof
Revisions (7); Sub-panel on Principles of Revision(6), Panel on
Medicinal Chemicals (33, including theworking group); Panel on
Antibiotics (9); Panel onBiologicals (8); Panel on Crude Drugs
(17); Panel onPharmaceutical Excipients (7): Panel on
Physico-Chemical Methods (12); Panel on Preparations (10);Panel on
Physico-Chemical Methods (8): Panel onBiological Tests (7); Panel
on Nomenclature (9); Panelon International Harmonization (2); and
Panel onPharmaceutical Water (7).
It should be noted that in the preparation of thedrafts for the
supplement, generous cooperation wasgiven by the Technical
Committee of the Pharmaceuti-cal Manufacturer's Association of
Osaka and ofTokyo, the Tokyo Crude Drugs Association, theJapan
Pharmaceutical Excipients Council, the JapanKampo Medicine
Manufacturers' Association, theJapan Flavor and Fragrance Materials
Association,the Japan Medical Plants Federation, the Japan
Phar-maceutical Manufacturers Association, and the JapanOilseeds
Processors Association.
In consequence of this revision, the JP 15th Editioncarries 1567
articles, owing to the addition of 90 arti-cles and the deletion of
6 articles.
Draft revisions covering subjects, the addition ofspecification
``Diethylene glycol and related sub-stances'' to the Purity of both
monographs Glycerinand Concentrated Glycerin was examined by the
Com-mittee on JP in September 2007, followed by PAFSCin October
2007, and then submitted to the Minister ofHealth, Labour and
Welfare.
This revision was promulgated on February 21, 2008by Ministerial
Notification No. 32 of MHLW, andbecame effective.
Draft revisions covering subjects, the addition ofspecification
``Over-sulfated chondroitin sulfate'' tothe Purity of monograph
Heparin Sodium and theresultant addition of Over-sulfated
Chondroitin Sul-fate Reference Standard to the list of Reference
Stand-ards in the General Tests were examined by the Com-mittee on
JP in July 2008, followed by PAFSC inOctober 2008, and then
submitted to the Minister ofHealth, Labour and Welfare.
This revision was promulgated on July 31, 2008 byMinisterial
Notification No. 417 of MHLW, andbecame effective.
Draft revisions covering subjects, the revision of theGeneral
Tests connected with the harmonization be-tween the three
pharmacopoeias, JP, EP and USP, therevision of the specification of
monograph Longuu
and the addition of a monograph Powdered Longguwere examined by
the Committee on JP in December2008, followed by PAFSC in March
2009, and thensubmitted to the Minister of Health, Labour and
Wel-fare.
This revision was promulgated on March 31, 2009by Ministerial
Notification No. 190 of MHLW, andbecame effective.
Draft revisions covering subjects in General Rulesfor Crude
Drugs, General Tests and Monographs, forwhich discussions were
completed between April 2007and March 2009, were prepared for a
supplement tothe JP 15. They were examined by the Committee onJP in
April 2009, followed by PAFSC in June 2009,and then submitted to
the Minister of Health, Labourand Welfare.
The supplement was named ``Supplement II to JP15th Edition'' and
promulgated on September 30,2009 by Ministerial Notification No.
425 of MHLW,and became effective on October 1, 2009.
Numbers of discussions in the panels to prepare therevision
drafts were as follows: Panel on Principles ofRevisions (3); Panel
on Medicinal Chemicals (23);Panel on Antibiotics (8); Panel on
Biologicals (8);Panel on Crude Drugs (21); Panel on
PharmaceuticalExcipients (10): Panel on Physico-Chemical
Methods(11, including the working group); Panel on Prepara-tions
(19, including the working group); Panel onPhysico-Chemical Methods
(9): Panel on BiologicalTests (9); Panel on Nomenclature (6); Panel
on Inter-national Harmonization (3); and Panel on Pharmaceu-tical
Water (8).
It should be noted that in the preparation of thedrafts for the
supplement, generous cooperation wasgiven by the Technical
Committee of the Pharmaceuti-cal Manufacturer's Association of
Osaka and ofTokyo, the Tokyo Crude Drugs Association, theJapan
Pharmaceutical Excipients Council, the HomeMedicine Association of
Japan, the Japan KampoMedicine Manufacturers' Association, the
JapanFlavor and Fragrance Materials Association, theJapan Medical
Plants Federation, the Japan ParentalDrug Association, the Japan
Reagent Association, theJapan Oilseeds Processors Association, and
the As-sociation of Membrane Separation Technology ofJapan.
In consequence of this revision, the JP 15th Editioncarries 1673
articles, owing to the addition of 106 arti-cles and the deletion
of 1 article.
Draft revisions covering subjects, the revision of theGeneral
Tests connected with the harmonization be-tween the three
pharmacopoeias, JP, EP and USP, theaddition of specification to the
Identification and the
-
iiiiiiJP XVI Preface
revision in the Purity of two monographs HeparinCalcium and
Heparin Sodium, and the several addi-tions to the Reference
Standards and the Reagents,Test Solutions were examined by the
Committee on JPin August 2009, followed by PAFSC in September2009,
and then submitted to the Minister of Health,Labour and
Welfare.
This revision was promulgated on July 30, 2010 byMinisterial
Notification No. 322 of MHLW, andbecame effective.
Draft revisions covering subjects in General Notices,General
Rules for Crude Drugs, General Rules forPreparations, General Tests
and Monographs, forwhich discussions were completed between April
2009and March 2010, were prepared for JP 16. They wereexamined by
the Committee on JP in September 2010,followed by PAFSC in October
2010, and then sub-mitted to the Minister of Health, Labour and
Welfare.
Numbers of discussions in the panels to prepare therevision
drafts were as follows: Panel on Principles ofRevisions (3); Panel
on Medicinal Chemicals (20);Panel on Antibiotics (5); Panel on
Biologicals (2);Panel on Crude Drugs (10); Panel on
PharmaceuticalExcipients (5): Panel on Physico-Chemical Methods(10,
including the working group); Panel on Prepara-tions (10, including
the working group); Panel onPhysico-Chemical Methods (8): Panel on
BiologicalTests (9, including the working group); Panel
onNomenclature (3); Panel on International Harmoniza-tion (1); and
Panel on Pharmaceutical Water (4).
It should be noted that in the preparation of thedrafts,
generous cooperation was given by the Techni-cal Committee of the
Pharmaceutical Manufacturer'sAssociation of Osaka and of Tokyo, the
Tokyo CrudeDrugs Association, the Japan Pharmaceutical Ex-cipients
Council, the Home Medicine Association ofJapan, the Japan Kampo
Medicine Manufacturers'Association, the Japan Flavor and Fragrance
Materi-als Association, the Japan Medical Plants Federation,the
Japan Parental Drug Association, the Japan Rea-gent Association,
the Japan Oilseeds Processors As-sociation, and the Association of
Membrane Separa-tion Technology of Japan.
In consequence of this revision, the JP 16th Editioncarries 1764
articles, owing to the addition of 106 arti-cles and the deletion
of 15 articles.
The principles of description and the salient pointsof the
revision in this volume are as follows:
1. The JP 16th Edition comprises the followingitems, in order:
Notification of MHLW; Contents;Preface; General Notices; General
Rules for CrudeDrugs; General Rules for Preparations; General
Tests,
Processes and Apparatus; Official Monographs; thenfollowed by
Infrared Reference Spectra and Ultravio-let-visible Reference
Spectra; General Information;Table of Standard Atomic Weights 2010
as an appen-dix; and a Cumulative Index.
2. The articles in General Rules for Preparations,Official
Monographs, Infrared Reference Spectra andUltraviolet-visible
Reference Spectra are respectivelyplaced in alphabetical order in
principle.
3. The following items in each monograph are putin the order
shown below, except that unnecessaryitems are omitted depending on
the nature of the drug:(1) English title(2) Commonly used
name(s)(3) Latin title (only for crude drugs)(4) Title in
Japanese(5) Structural formula or empirical formula(6) Molecular
formula and molecular mass(7) Chemical name(8) CAS Registry
Number(9) Origin
(10) Limits of the content of the ingredient(s) and/orthe unit
of potency
(11) Labeling requirements(12) Method of preparation(13)
Description/Description of crude drugs(14) Identification tests(15)
Specific physical and/or chemical values(16) Purity tests(17) Loss
on drying or Ignition, or Water(18) Residue on ignition, Total ash
or Acid-insoluble
ash(19) Tests being required for pharmaceutical prepa-
rations and other special tests(20) Isomer ratio(21) Assay or
the content of the ingredient(s)(22) Containers and storage(23)
Expiration date(24) Others
4. In each monograph, the following physical andchemical values
representing the properties and qualityof the drug are given in the
order indicated below, ex-cept that unnecessary items are omitted
depending onthe nature of drug:(1) Alcohol number(2) Absorbance(3)
Congealing point(4) Refractive index(5) Osmolarity(6) Optical
rotation(7) Viscosity
-
iviv JP XVIPreface
(8) pH(9) Specific gravity
(10) Boiling point(11) Melting point(12) Acid value(13)
Saponification value(14) Ester value(15) Hydroxyl value(16) Iodine
value
5. Identification tests comprise the followingitems, which are
generally put in the order givenbelow:(1) Coloration reactions(2)
Precipitation reactions(3) Decomposition reactions(4)
Derivatives(5) Infrared and/or ultraviolet-visible absorption
spectrometry(6) Special reactions(7) Cations(8) Anions
6. Purity tests comprise the following items, whichare generally
put in the order given below, except thatunnecessary items are
omitted depending on the natureof drug:(1) Color(2) Odor(3) Clarity
and/or color of solution(4) Acidity or alkalinity(5) Acidity(6)
Alkalinity(7) Chloride(8) Sulfate(9) Sulfite
(10) Nitrate(11) Nitrite(12) Carbonate(13) Bromide(14)
Iodide(15) Soluble halide(16) Thiocyanate(17) Selenium(18) Cationic
salts(19) Ammonium(20) Heavy metals(21) Iron(22) Manganese(23)
Chromium(24) Bismuth(25) Tin(26) Aluminum(27) Zinc
(28) Cadmium(29) Mercury(30) Copper(31) Lead(32) Silver(33)
Alkaline earth metals(34) Arsenic(35) Foreign matters(36) Related
substances(37) Residual solvent(38) Other impurities(39) Readily
carbonizable substances
7. The following paragraphs of General Noticeswere revised:(1)
Paragraph 3: The sentence ``The distinction of
the preparations name of Fine Granules andPowders follows
according to the definition inthe section of ``Powders'' of General
Rules forPreparations.'' was deleted according to the re-vision of
General Rules for Preparations.
(2) Paragraph 4: Exampled name of preparationswas revised in
accordance with the current statusof listed monographs.
(3) Paragraph 8: Atomic masses the JP refers towas revised to
the table of ``Standard AtomicWeights 2010''.
(4) Paragraph 9: Being often used two units, pScm1 and CFU, were
added.
(5) Paragraph 16: The definition of water used tomeasure the
number of drops of a droppingdevice was revised in accordance with
the revi-sion of Paragraph 20.
(6) Paragraph 20: The provision of water used forthe test of
drugs was revised according to the re-vision of monograph Purified
Water.
(7) Other descriptions were improved.
8. To Paragraph 1 of General Rules for CrudeDrugs the following
items were added:(1) Aluminum Silicate Hydrate with Silicon
Dioxide(2) Brown Rice(3) Koi(4) Sesame
9. The General Rules for Preparations was revisedas follows in
general:
The addition of dosage forms which had not havebeen prescribed,
the classification of dosage formsbased on the route and/or site of
administration, andthe definition of individual dosage forms and
the teststo be applied to them.
10. The following items in General Tests, Pro-cesses and
Apparatus were revised:
-
vvJP XVI Preface
(1) 2.01 Liquid Chromatography(2) 2.46 Residual Solvents Test(3)
2.51 Conductivity Measurement(4) 2.54 pH Determination(5) 2.58
X-Ray Powder Diffraction Method(6) 3.01 Determination of Bulk and
Tapped Densi-
ties(7) 4.01 Bacterial Endotoxins Test(8) 4.05 Microbial Limit
Test(9) 4.06 Sterility Test
(10) 5.02 Microbial Limit Test for Crude Drugs(11) 6.03 Particle
Size Distribution Test for Prepara-
tions(12) 6.07 Insoluble Particulate Matter Test for Injec-
tions(13) 6.08 Insoluble Particulate Matter Test for Oph-
thalmic Solutions(14) 7.02 Test Methods for Plastic
Containers(15) 8.01 Sterilization and Aseptic Manipulation
11. The title of the following item in GeneralTests, Processes
and Apparatus was revised:
8.01 Sterilization and Aseptic Manipulation
12. The following Reference Standards were ad-ded:
Atorvastatin CalciumAlendronate SodiumGlimepirideSarpogrelate
HydrochlorideDonepezil
HydrochlorideTrehaloseNateglinideFexofenadine
HydrochlorideFluvoxamine MaleatePropiverine HydrochloridePemirolast
PotassiumRabeprazole SodiumRisedronic Acid
13. The following Reference Standard was revisedin Japanese
title:
Tyrosine
14. The following Reference Standards were delet-ed from the
list of 9.01 Reference Standards:
Astromicin SulfateInsulinSisomicin SulfateCefapirin
SodiumCefuroxime SodiumNetilmicin Sulfate
15. The intended use of each individual ReferenceStandard was
deleted from the list of 9.01 Reference
Standards.
16. Some of the names of the reagents or test solu-tions under
9.41 Reagents, Test Solutions were main-tained.
17. To the each individual item in the GeneralTests, Processes
and Apparatus, chapter and sectionnumbers were putted.
18. The following substans were newly added tothe Official
Monographs:
Aciclovir SyrupAciclovir InjectionAciclovir for
SyrupAcetylcysteineAtorvastatin Calcium HydrteAtorvastatin Calcium
TabletsAmikacin Sulfate for InjectionAlendronate Sodium
HydrateAlendronate Sodium InjectionAlendronate Sodium
TabletsL-Isoleucine, L-Leucine and L-Valine
GranulesEbastineEbastine Orally Disintegrating TabletsEbastine
TabletsCarvedilolCarvedilol TabletsCandesartan CilexetilCandesartan
Cilexetil TabletsQuinapril HydrochlorideQuinapril Hydrochloride
TabletsGlimepirideGlimepiride TabletsL-Glutamic acidSarpogrelate
HydrochlorideSarpogrelate Hydrochloride Fine GranulesSarpogrelate
Hydrochloride TabletsDiazepam TabletsPurified Water in
ContainersSterile Water for Injection in ContainersSpironolactone
TabletsZolpidem Tartrate TabletsTamsulosin Hydrochloride
Extended-release TabletsTamoxifen CitratePrecipitated Calcium
Carbonate Fine GranulesPrecipitated Calcium Carbonate
TabletsTemocapril HydrochlorideTemocapril Hydrochloride
TabletsTerbinafine HydrochlorideTerbinafine Hydrochloride
CreamTerbinafine Hydrochloride SolutionTerbinafine Hydrochloride
SprayDoxazosin Mesilate Tablets
-
vivi JP XVIPreface
Donepezil HydrochlorideDonepezil Hydrochloride Fine
GranulesDonepezil Hydrochloride TabletsTrehalose
HydrateNateglinideNateglinide TabletsL-Lactic AcidSodium L-Lactate
SolutionHaloperidol Fine GranulesPioglitazone Hydrochloride
TabletsL-HistidineL-Histidine Hydrochloride HydrateFamotidine
InjectionFexofenadine HydrochlorideButenafine
HydrochlorideButenafine Hydrochloride CreamButenafine Hydrochloride
SolutionButenafine Hydrochloride SprayPravastatin Sodium Fine
GranulesPravastatin Sodium SolutionPravastatin Sodium
TabletsFluconazoleFluvoxamine MaleateFluvoxamine Maleate
TabletsFlecainide AcetateFlecainide Acetate TabletsPropiverine
HydrochloridePropiverine Hydrochloride TabletsProbucol Fine
GranulesProbucol TabletsL-ProlineBetamipronPemirolast
PotassiumPemirolast Potassium for SyrupPemirolast Potassium
TabletsBeraprost SodiumBeraprost Sodium TabletsMupirocin Calcium
OintmentMethotrexate CapsulesMosapride Citrate PowderRabeprazole
SodiumRisperidoneRisperidone Fine GranulesRisperidone Oral
SolutionRisperidone TabletsSodium Risedronate HydrateSodium
Risedronate TabletsRoxatidine Acetate Hydrochloride
Extended-releaseTabletsRoxatidine Acetate Hydrochloride for
InjectionOrengedokuto ExtractAluminum Silicate Hydrate with Silicon
DioxideKoi
Brown RiceSesameSaikokeishito ExtractSaibokuto
ExtractShakuyakukanzoto ExtractJuzentaihoto ExtractShosaikoto
ExtractShoseiryuto ExtractMukoi-Daikenchuto ExtractChutosan
ExtractBakumondoto ExtractRikkunshito Extract
19. The following monographs were revised:Zinc Oxide
OintmentAjmaline TabletsAscorbic Acid PowderAscorbic Acid
InjectionAspirin TabletsAcetylcholine Chloride for
InjectionAzelastine Hydrochloride GranulesAdrenalinAdrenalin
SolutionOpium TinctureOpium Alkaloids Hydrochloride InjectionOpium
Alkaloids and Atropine InjectionOpium Alkaloids and Scopolamine
InjectionWeak Opium Alkaloids and Scopolamine InjectionMeglumine
Sodium Amidotrizoate InjectionAmitriptyline Hydrochloride
TabletsAminophylline InjectionL-AlanineL-Arginine Hydrochloride
InjectionAllopurinolSulfur and Camphor LotionSodium Iotalamate
InjectionMeglumine Iotalamate InjectionIsoniazid InjectionIsoniazid
TabletsIdoxuridine Ophthalmic SolutionImipramine
HydrochlorideIrsogladine Maleate Fine GranulesIndigocarmine
InjectionInsulin Human (Genetical Recombination)Indometacin
CapsulesIndometacin SuppositoriesUrsodeoxycholic Acid
GranulesEcabet Sodium GranulesEstradiol Benzoate InjectionEstradiol
Benzoate Injection (Aqueous Suspension)Estriol TabletsEstriol
Injection (Aqueous Suspension)Etacrynic Acid Tablets
-
viiviiJP XVI Preface
Ethanol for DisinfectionEtizolam Fine
GranulesEthinylestradiolEthinylestradiol TabletsEtilefrine
Hydrochloride TabletsEdrophonium Chloride InjectionEphedrine
Hydrochloride InjectionEphedrine Hydrochloride Tablets10z Ephedrine
Hydrochloride PowderErgometrine Maleate Hydrochloride
InjectionErgometrine Maleate Hydrochloride Tablets10z Sodium
Chloride InjectionHydrochloric Acid LemonadeCompound Oxycodone
InjectionCompound Oxycodone and Atropine InjectionFructose
InjectionPotash SoapCarmelloseCarmellose CalciumCarmellose
SodiumXylitol InjectionDiagnostic Sodium Citrate SolutionSodium
Citrate Injection for TransfusionGlycerin and Potash
SolutionAbsorptive CreamHydrophilic CreamClindamycin
HydrochlorideCresol SolutionSaponated Cresol SolutionClofibrate
CapsulesClomifene Citrate TabletsChlordiazepoxide
PowderChlordiazepoxide TabletsChlorpheniramine Maleate
PowderChlorpheniramine Maleate TabletsChlorpropamide
TabletsChlorpromazine Hydrochloride InjectionKetoconazole
SolutionKetoconazole Cream10z Codeine Phosphate PowderCodeine
Phosphate TabletsCompound Salicylic Acid
SpiritOxygenDiazepamDigitoxin TabletsDiclofenamide
TabletsDistigmine Bromide TabletsDydrogesterone TabletsZinostatin
Stimalamer1z Dihydrocodeine Phosphate PowderDimenhydrinate
TabletsSilver Nitrate Ophthalmic SolutionWater
Purified WaterSterile Purified Water in ContainersWater for
InjectionDried Aluminum Hydroxide Gel Fine GranulesSuxamethonium
Chloride InjectionSuxamethonium Chloride for
InjectionSpironolactoneSulpyrine InjectionSulfobromophthalein
Sodium InjectionIsotonic Sodium Chloride SolutionCefaclorCefaclor
Compound GranulesCefaclor Fine GranulesCefazolin Sodium
HydrateCefatrizine Propylene Glycolate for SyrupCefalexinCefalexin
for SyrupCefalotin SodiumCefixime HydrateCefepime Dihydrochloride
HydrateCefcapene Pivoxil Hydrochloride HydrateCefcapene Pivoxil
Hydrochloride Fine GranulesCefditoren Pivoxil Fine GranulesCefdinir
Fine GranulesCeftibuten HydrateCefteram Pivoxil Fine
GranulesCefpodoxime ProxetilCefroxadine for
SyrupSevofluraneD-Sorbitol SolutionTacrolimus HydrateTalcSodium
Bicarbonate InjectionSimple SyrupThiamazole TabletsThiamine
Chloride Hydrochloride PowderThiamine Chloride Hydrochloride
InjectionThiopental Sodium for InjectionSodium Thiosulfate
InjectionNitrogenTipepidine Hibenzate TabletsL-TyrosineTestosterone
Enanthate InjectionDeslanoside InjectionDehydrocholic Acid
InjectionDopamine Hydrochloride InjectionTriclofos Sodium
SyrupTrihexyphenidyl Hydrochloride TabletsTrimethadione
TabletsTolnaftate SolutionTolbutamide TabletsDroxidopa Fine
GranulesTroxipide Fine Granules
-
viiiviii JP XVIPreface
Rape Seed OilNaphazoline and Chlorpheniramine
SolutionNicardipine Hydrochloride InjectionNicotinic Acid
InjectionNicomol TabletsCarbone DioxideNicergoline
PowderNitroglycerin TabletsNeostigmine Methylsulfate
InjectionNoradrenaline InjectionNorgestrel and Ethinylestradiol
TabletsBaclofen TabletsPapaverine Hydrochloride InjectionCalcium
Paraaminosalicylate GranulesBisacodyl SuppositoriesHydralazine
Hydrochloride PowderHydralazine Hydrochloride TabletsHydralazine
Hydrochloride for InjectionPiperazine Phosphate TabletsFamotidine
PowderFaropenem Sodium for SyrupPhenytoin PowderPhenytoin
TabletsPhenobarbital10z Phenobarbital PowderLiquefied
PhenolPhenolated WaterPhenolated Water for DisinfectionPhenol and
Zinc Oxide LinimentPhenolsulfonphthalein InjectionGlucose
InjectionPrazepam TabletsFlurazepam CapsulesPrednisolone
TabletsPrednisolone Sodium Succinate for InjectionProcaine
Hydrochloride InjectionProchlorperazine Maleate
TabletsPropylthiouracil TabletsFlopropione
CapsulesProbenecidProbenecid TabletsFlomoxef SodiumBetamethasone
Valerate and Gentamicin SulfateCreamBetamethasone Sodium
PhosphatePethidine Hydrochloride InjectionPerphenazine
TabletsPerphenazine Maleate TabletsBenzalkonium Chloride
SolutionBenzyl AlcoholBenzethonium Chloride SolutionFormalin
WaterMercurochrome Solution
D-Mannitol InjectionYellow BeeswaxMinocycline
HydrochlorideMinocycline Hydrochloride TabletsMinocycline
Hydrochloride for InjectionAlum Solution10z dl-Methylephedrine
Hydrochloride PowderMethyltestosterone TabletsMethyldopa
TabletsMetenolone Enanthate InjectionMetronidazole
TabletsMepivacaine HydrochlorideMefruside TabletsMeropenem
HydrateMorphine Hydrochloride TabletsMorphine Hydrochloride
InjectionMorphine and Atropine InjectionFolic Acid TabletsFolic
Acid InjectionMeglumine Sodium Iodamide InjectionIodine
TinctureDilute Iodine TinctureDental Iodine GlycerinCompound Iodine
GlycerinIodine, Salicylic Acid and Phenol SpiritLatamoxef
SodiumLanatoside C TabletsLiothyronine Sodium TabletsL-Lysine
HydrochlorideL-Lysine AcetateLidocaine InjectionRifampicin
CapsulesRiboflavin PowderRiboflavin Sodium Phosphate InjectionZinc
Sulfate Ophthalmic SolutionMagnesium Sulfate MixtureMagnesium
Sulfate InjectionRinger's SolutionDibasic Sodium Phosphate
HydrateReserpine TabletsReserpine InjectionLevallorphan Tartrate
InjectionLevothyroxine Sodium TabletsSweet Hydrangea
LeafAloePowdered AloeFoeniculated Ammonia SpiritEpimedium
HerbFennel OilTurmericPowdered TurmericBearberry LeafUva Ursi
Fluidextract
-
ixixJP XVI Preface
Corydalis TuberPowdered Corydalis TuberPolygala RootPowdered
Polygala RootPueraria RootKamishoyosan ExtractGlycyrrhiza
ExtractCrude Glycyrrhiza ExtractAgarPlatycodon FluidextractCatalpa
FruitApricot KernelApricot Kernel WaterBitter
TinctureKeishibukuryogan ExtractSafflowerRed GinsengMagnolia
BarkPowdered Magnolia BarkGoshajinkigan ExtractEuodia
FruitCondurangoCondurango FluidextractBupleurum RootSaireito
ExtractSaffronGardenia FruitPowdered Gardenia FruitCornus
FruitJujube SeedEleutherococcus Senticosus RhizomeSodium
Bicarbonate and Bitter Tincture MixtureCimicifuga RhizomeMagnolia
FlowerShimbuto ExtractSenega SyrupToad VenomAtractylodes Lancea
RhizomePerilla HerbAlisma RhizomePowdered Alisma RhizomeUncaria
HookPowdered Polyporus SclerotiumCitrus Unshiu PeelCapsicumPowdered
CapsicumCapsicum TincturePeach KernelPowdered Peach KernelOrange
Peel SyrupOrange Peel TinctureIpecacPowdered Ipecac
Ipecac SyrupEucommia BarkGinsengPowdered GinsengHachimijiogan
ExtractHoneyMentha WaterGlehnia Root and RhizomeHangekobokuto
ExtractAngelica Dahurica RootAtractylodes RhizomePoria
SclerotiumBelladonna ExtractSinomenium Stem and
RhizomeSaposhnikovia Root and RhizomeMoutan BarkPowdered Moutan
BarkHochuekkito ExtractNux Vomica ExtractNux Vomica Extract
PowderNux Vomica TinctureOyster ShellPowdered Oyster
ShellRyokeijutsukanto ExtractScopolia ExtractScopolia Extract
PowderRoyal Jelly
20. The following monographs were deleted:Astromicin
SulfateIsophane Insulin Injection (Aqueous
Suspension)InsulinInsulin InjectionInsulin Zinc Injection (Aqueous
Suspension)Insulin Zinc Protamine Injection (Aqueous
Suspen-sion)Crystalline Insulin Zinc Injection (Aqueous
Suspen-sion)Amorphous Insulin Zinc Injection (Aqueous
Sus-pension)Sisomicin SulfateCefapirin SodiumCefuroxime
SodiumNetilmicin SulfateBufexamacBufexamac CreamBufexamac
Ointment
21. The following monographs were changed inJapanese title:
Absorptive CreamHydrophilic CreamSterile Purified Water in
ContainersCefixime Hydrate
-
xx JP XVIPreface
L-TyrosineL-Lysine HydrochlorideL-Lysine Acetate
22. The following monographs were revised in thecontent limit
more precise:
Ajmaline TabletsAscorbic Acid PowderAscorbic Acid
InjectionAspirin TabletsAcetylcholine Chloride for
InjectionMeglumine Sodium Amidotrizoate InjectionAmitriptyline
Hydrochloride TabletsAminophylline InjectionSodium Iotalamate
InjectionMeglumine Iotalamate InjectionIsoniazid TabletsIsoniazid
InjectionIdoxuridine Ophthalmic SolutionImipramine
HydrochlorideIndigocarmine InjectionIndometacin CapsulesIndometacin
SuppositoriesEstradiol Benzoate InjectionEstradiol Benzoate
Injection (Aqueous Suspension)Estriol TabletsEstriol Injection
(Aqueous Suspension)Etacrynic Acid TabletsEthinylestradiol
TabletsEdrophonium Chloride InjectionEphedrine Hydrochloride
TabletsEphedrine Hydrochloride InjectionErgometrine Maleate
TabletsErgometrine Maleate InjectionFructose InjectionXylitol
InjectionClofibrate Capsules ExtractClomifene Citrate
TabletsChlordiazepoxide PowderChlordiazepoxide
TabletsChlorpropamide TabletsChlorpromazine Hydrochloride
InjectionCodeine Phosphate TabletsDigitoxin TabletsDiclofenamide
TabletsDistigmine Bromide TabletsDimenhydrinate
TabletsDydrogesterone TabletsSuxamethonium Chloride
InjectionSuxamethonium Chloride for InjectionSulpyrine
InjectionSulfobromophthalein Sodium InjectionD-Sorbitol
Solution
Sodium Bicarbonate InjectionThiamazole TabletsThiamine Chloride
Hydrochloride PowderThiamine Chloride Hydrochloride
InjectionThiopental Sodium for InjectionSodium Thiosulfate
InjectionTipepidine Hibenzate TabletsTestosterone Enanthate
InjectionDeslanoside InjectionDehydrocholic Acid InjectionDopamine
Hydrochloride InjectionTriclofos Sodium SyrupTrihexyphenidyl
Hydrochloride TabletsTrimethadione TabletsTolnaftate
SolutionTolbutamide TabletsNicardipine Hydrochloride
InjectionNicotinic Acid InjectionNicomol TabletsNitroglycerin
TabletsNeostigmine Methylsulfate InjectionNoradrenaline
InjectionNorgestrel and Ethinylestradiol TabletsBaclofen
TabletsPapaverine Hydrochloride InjectionBisacodyl
SuppositoriesHydralazine Hydrochloride PowderHydralazine
Hydrochloride TabletsHydralazine Hydrochloride for
InjectionPiperazine Phosphate TabletsGlucose InjectionPrazepam
TabletsFlurazepam CapsulesPrednisolone TabletsPrednisolone Sodium
Succinate for InjectionProcaine Hydrochloride
InjectionProchlorperazine Maleate TabletsPropylthiouracil
TabletsProbenecid TabletsPethidine Hydrochloride
InjectionPerphenazine TabletsPerphenazine Maleate
TabletsBenzalkonium Chloride SolutionBenzethonium Chloride
SolutionD-Mannitol InjectionMethyldopa TabletsMetenolone Enanthate
InjectionMefruside TabletsMorphine Hydrochloride TabletsMorphine
Hydrochloride InjectionFolic Acid TabletsFolic Acid
InjectionLanatoside C Tablets
-
xixiJP XVI Preface
Liothyronine Sodium TabletsLidocaine InjectionRiboflavin
PowderRiboflavin Sodium Phosphate InjectionMagnesium Sulfate
InjectionReserpine TabletsReserpine InjectionLevallorphan Tartrate
InjectionLevothyroxine Sodium Tablets
23. The monographs which `Method of prepara-tion' was revised
according to the revision of GeneralRules for Preparations were as
follows:
Ascorbic Acid PowderIrsogladine Maleate Fine GranulesEtizolam
Fine Granules10z Ephedrine Phosphate PowderChlordiazepoxide
PowderChlorpheniramine Maleate PowderKetoconazole
SolutionKetoconazole Cream1z Codeine Phosphate Powder1z
Dihydrocodeine Phosphate PowderDried Aluminum Hydroxide Gel Fine
GranulesCefaclor Fine GranulesCefatrizine Propylene Glycolate for
SyrupCefalexin for SyrupCefcapene Pivoxil Hydrochloride Fine
GranulesCefditoren Pivoxil Fine GranulesCefdinir Fine
GranulesCefteram Pivoxil Fine GranulesCefroxadine for
SyrupDroxidopa Fine GranulesTroxipide Fine GranulesNicergoline
PowderHydralazine Hydrochloride PowderFamotidine PowderFaropenem
Sodium for SyrupPhenytoin Powder10z Phenobarbital
PowderBetamethazone Valerate and Gentamicin SulfateCream10z
dl-Methylephedrine Hydrochloride PowderRiboflavine Powder
24. The monographs which `Particle size' wasdeleted according to
the revision of General Rules forPreparations were as follows:
Azelastine Hydrochloride GranulesUrsodeoxycholic Acid
GranulesEcabet Sodium GranulesChlorpheniramine Maleate
PowderCefaclor Compound GranulesNicergoline Powder
Calcium Paraaminosalicylate Granules10z Phenobarbital Powder
25. The monographs which `Method of prepara-tion' was revised
according to the revision of themonograph ``Water'' were as
follows:
Adrenaline SolutionOpium TinctureOpium Alkaloids Hydrochloride
InjectionOpium Alkaloids and Atropine InjectionOpium Alkaloids and
Scopolamine InjectionWeak Opium Alkaloids and Scopolamine
InjectionMeglumine Sodium Amidotrizoate InjectionL-Arginine
Hydrochloride InjectionSulfur and Camphor LotionSodium Iotalamate
InjectionMeglumine Iotalamate InjectionEthanol for Disinfection10z
Sodium Chloride InjectionHydrochloric Acid LemonadeCompound
Oxycodone InjectionCompound Oxycodone and Atropine InjectionPotash
SoapDiagnostic Sodium Citrate SolutionSodium Citrate Injection for
TransfusionGlycerin and Potash SolutionAbsorptive CreamHydrophilic
CreamCresol SolutionSaponated Cresol SolutionCompound Salicylic
Acid SpiritSilver Nitrate Ophthalmic SolutionIsotonic Sodium
Chloride SolutionSimple SyrupDeslanoside InjectionNaphazoline and
Chlorpheniramine SolutionPhenolated Water for
DisinfectionPhenolated WaterPhenol and Zinc Oxide
LinimentPhenolsulfonphthalein InjectionBenzalkonium Chloride
SolutionBenzethonium Chloride SolutionFormalin WaterMercurochrome
SolutionAlum SolutionMorphine and Atropine InjectionMeglumine
Sodium Iodamide InjectionIodine TinctureDilute Iodine
TinctureDental Iodine GlycerinCompound Iodine GlycerinIodine,
Salicylic Acid and Phenol SpiritZinc Sulfate Ophthalmic
Solution
-
xiixii JP XVIPreface
Magnesium Sulfate MixtureRinger's SolutionFoeniculated Ammonia
SpiritUva Ursi FluidextractGlycyrrhiza ExtractCrude Glycyrrhiza
ExtractPlatycodon FluidextractApricot Kernel WaterBitter
TinctureCondurango FluidextractSodium Bicarbonate and Bitter
Tincture MixtureSenega SyrupOrange Peel SyrupOrange Peel
TinctureIpecac SyrupMentha WaterBelladonna ExtractNux Vomica
ExtractNux Vomica Extract PowderNux Vomica TinctureScopolia
ExtractScopolia Extract Powder
26. Monographs in which the test ``Content deter-mination'' was
changed to ``Assay'' were as follows:
AloePowdered AloeTurmericPowdered TurmericUva UrsiUva Ursi
FluidextractCorydalis TuberPowdered Corydalis TuberApricot
KernelMagnolia BarkPowdered Magnolia BarkBupleurum RootGardenia
FruitPowdered Gardenia FruitCornus FruitToad VenomPerilla
HerbUncaria HookCapsicumPowdered CapsicumCapsicum TincturePeach
KernelPowdered Peach KernelIpecacPowdered IpecacIpecac SyrupMoutan
BarkPowdered Moutan Bark
Royal JellyThose who were engaged in the preparation of JP
16
are as follows:Norio AimiFumiaki AkahoriTeruo AmagasaMitsuo
AokiKiichi AonukiNobuo Aoyagi**Hiroshi AsamaToshiki AsanoKazuhide
AshizawaShinichiro AsoYukio AsoHiroyuki AraiKeiko ArimotoTakashi
BambaMasahiko ChikumaMakoto EmuraHiroyuki FuchinoShigeyuki
FujikuraKiyoshi FukuharaAkihiko FujiseGoro FunamotoYukihiro
GodaTakashi GotoNoriaki HabasakiTakashi HakamatsukaRuri
HanajiriKentaro HanadaToshikazu HaradaKouji HasegawaMitsuru
Hashida*Susumu HashimotoHarumi HatanoRika HatanoTakao
Hayakawa*Masahiro HayashiYoshinori HayashiKenji HiguchiKatsuhuto
HiramatsuYuuki HirataFusayoshi HirayamaTakashi HiroshimaYukio
HiyamaNaoki HosonoKenji HosoyaKunimoto HottaAkihiro HurukawaMasashi
HyugaTakanori IchikawaNobukazu IgoshiKazuhiko Ikegami
-
xiiixiiiJP XVI Preface
Koichi InubushiKenichi InuiAkiko IshiiTsuneo IshizukaShigeru
ItaiChizuko ItohYuji ItoTakashi ItohMasao IzakiKenichi IzutsuAkemi
KaiKazuaki KakehiTakemine KanaiMotoko KankeHirohito KatayamaHaru
KatoKumiko KatoYoshiaki KatoNoriko KatoriSatoshi KawadaNobuo
KawaharaUrao KawakamiToru KawanishiYoshihiko KawarasakiNana
KawasakiToshisuke KawasakiYoshiaki KawashimaKeiji KijimaYutaka
KikuchiYuuichi KikuchiYasuhiro KishimotoMitsukazu KitadaFumiyuki
KiuchiJunko KizuTakashi KobayashiYukari KogaMasayoshi KohaseTatsuo
KoideShigeo KojimaHiroyasu KokuboKatsuko KomatsuHitoshi
KomatsubaraAkio KomuraTetsuya KondaToshifumi KondaKenji KondoSeizo
KondoKenichi KumasakaTakao KunisadaMasaaki KuriharaHiroyuki
KuritaHaruo KuriyamaFumiyo Kusu
Kumiko KusuyamaMasako MaedaMidori MakitaMasahiko
MarumotoYoshihisa MatsudaNorio MatsukiEiichi MikamiSatoshi
MinobeTakao MitsuhashiTsuyoshi MiuraTsuyoshi MiyagawaHiroto
MiyamotoNaoki MiyataTamaki MiyazakiMichinao MizugakiTaiichi
MizutaMitsuo MoriKaoru MorikawaSeiki MorimotoKatsuhiro
MorisawaOsamu MoritaTakashi MoritaToshimi MuraiMasashi MuroiHiroaki
NagashigeTakahiro NaitoSinsaku NakagawaEmi NakajimaHiroshi
NakamuraTatsuya NakanoTatsumi NakashimaMitsuo NanauraMasaaki
NaotsukaMasao NasuShingo NiimiYutaka NishiharaHiroshi
NishimuraAtsushi NukanobuSumiaki ObaShukichi OchiaiYasumitsu
OguraAtsuyuki OhtsukiRyozo OishiSatoshi OkadaMinoru OkadaNorio
OkahanaKimiya OkazakiAkira OkonogiTsuneo OkuboHaruhiro
OkudaTakamasa OkugawaYuko OsumiMasami Otsuka
-
xivxiv JP XVIPreface
Tadashi OuchiKazuhiro OwadaKenji SaikiYukio SaitoYoshikazu
SakagamiEiji SakaiTomoaki SakamotoShingou SakuraiTomofumi
SantaHideki SasakiHiroshi SasakiKunio SasakiTomoko SasakiTsuguo
SasakiKazumichi SasaokiMotoyoshi SatakeKyoko SatoMichiko
SekiguchiSetsuko SekitaYasuo ShimadaKesamitsu ShimizuKozo
ShimodaKyoko ShimuraOsamu ShirokizawaOsamu ShirotaTakuji ShodaJunya
SoumaTakashi SonobeKeiichi SudoShoko SueyoshiShinji SugayaDaisuke
SugiuraHisakazu SunadaHideyo SuzukiMikio SuzukiShinichi TadakiNobuo
TaguchiToshio TakachiWataru TakadaYoshikazu TakahashiKunihiro
TakaiMasaki TakaoKikuo TakateraOsami TakedaTadahiro TakedaYasushi
TakedaHirohumi TakeuchiToyoshige TanabeHaruo TanakaMasaaki
TanakaToshihiro TanakaKenichi Tanamoto**Tsuyoshi Tanimoto
Yoshikazu TashiroKatsuhide TeradaReiko TeraokaKeijiro
TerashitaSusumu TerabayashiMasafumi TeshigawaraHiroshi
TokunagaKiyoshi TomiokaMotowo TomitaHiroyuki TomitsukaYosuke
TsujiHiroyuki TsujimotoKazunori TsutsuiHideya TugeEriko
UchidaYoshimasa UeharaAtsuhiro UetakeKazuichi UmemotoMasaaki
WadaEiji WatanabeHaruo WatanabeTakehiko YajimaToshiyasu
YamadaTeruhide YamaguchiTetsuji YamaguchiKeiichi YamamotoKeiji
YamamotoTosuke YamamotoChikamasa YamashitaTakeshi YamazakiMasato
YasuharaShiho YasuoHikaru YodenHitoo YoshidaKumi YoshidaSumie
YoshiokaChikako YomotaEtsuo Yonemochi
*: Chairman, the Committee on JP**: Acting Chairman, the
Committee on JP
-
11
GENERAL NOTICES
1. The official name of this pharmacopoeia is, and may be
abbreviated as , 16, JP XVI or JP 16.2. The English name of this
pharmacopoeia is TheJapanese Pharmacopoeia, Sixteenth Edition.3.
Among drugs, the Japanese PharmacopoeiaDrugs (the JP Drugs) are
those specified in themonographs. The title names and the commonly
usednames adopted in the monographs should be used asofficial
names. In the drug monographs, in addition toEnglish name, chemical
names or Latin names can bementioned in the titles, as
appropriate.4. ``Crude Drugs and related drugs'' are placedtogether
in the posterior part of the Official Mono-graphs. These include:
Crude Drugs being applied therequirements of the General Rules for
Crude Drugs, orPowders, Extracts, Tinctures, Syrups, Spirits,
Fluidex-tracts or Suppositories containing Crude Drugs as theactive
ingredient, combination preparations contain-ing Crude Drugs as the
principal active ingredient.5. Drugs are to be tested according to
the provisionsgiven in the pertinent monographs, General
Notices,General Rules for Crude Drugs, General Rules
forPreparations, and General Tests for their conformityto the
Japanese Pharmacopoeia. However, the itemsof ``Description'' and
``Storage'' under Containersand storage in the monographs on
preparations aregiven for information, and should not be taken
asindicating standards for conformity.6. In principle, unless
otherwise specified, animalsused for preparing the JP Drugs or
their sourcematerials must be healthy.7. In this English version,
the JP Drugs described inthe monographs begin with a capital
letter.8. The molecular formulas or constitution formulasin
parentheses ( ) after the name of drugsor chemicals designate
chemically pure substances.Atomic masses adopted in the Japanese
Pharmaco-poeia conform to the table of ``Standard AtomicWeights
2010''. Molecular masses are indicated to twodecimal places rounded
from three decimals.9. The following abbreviations are used for the
prin-cipal units.
meter mcentimeter cmmillimeter mmmicrometer mm
nanometer nmkilogram kggram gmilligram mgmicrogram mgnanogram
ngpicogram pgCelsius degree 9Cmole molmillimole mmolsquare
centimeter cm2
liter Lmilliliter mLmicroliter mLmegahertz MHzper centimeter
cm1
newton Nkilopascal kPapascal Papascal second Pasmillipascal
second mPassquare millimeter per second mm2/slux lxmole per liter
mol/Lmillimole per liter mmol/Lmass per cent zmass parts per
million ppmmass parts per billion ppbvolume per cent volzvolume
parts per million vol ppmmass per volume per cent w/vzmicrosimens
per centimeter mScm1
endotoxin unit EUcolony forming unit CFU
Note: ``ppm'' used in the Nuclear Magnetic ResonanceSpectroscopy
indicates the chemical shift, and``w/vz'' is used in the formula or
composition ofpreparations.10. The unit used for expressing the
potency of drugis recognized as the quantity of drug. Usually it is
ex-pressed by a definite quantity of a definite standardsubstance
which shows a definite biological activity,and differs according to
each drug. The units aredetermined, in principle, by comparison
with each ref-erence standard by means of biological methods.
Theterm ``Unit'' used for the JP articles indicates the unit
-
2
Table 1
Sieve No. 4 6.5 8.6 18 50 100 200
NominalDesignationof sieve
4750 mm 2800 mm 2000 mm 850 mm 300 mm 150 mm 75 mm
Names ofthe drugswhich passthrough therespectivesieves
Coarsecutting
Moderate-ly
finecutting
Finecutting
Coarsepowder
Moderate-ly
finepowder
Finepowder
Veryfine
powder
2 JP XVIGeneral Notices
defined in the Japanese Pharmacopoeia.11. The statement ``Being
specified separately.'' inthe monographs means that the tests are
to be speci-fied when the drugs are granted approval based on
thePharmaceutical Affairs Law.12. When an assurance that a product
is of the JPDrug quality is obtained consistently from data
de-rived from the manufacturing process validationstudies, and from
the records of appropriate manufac-turing process control and of
the test results of thequality control, some of the test items in
the mono-graph being performed for the release of a productmay be
omitted as occasion demands.13. The test methods specified in the
Japanese Phar-macopoeia can be replaced by alternative methodswhich
give better accuracy and precision. However,where a difference in
test results is suspected, only theresult obtained by the procedure
given in thePharmacopoeia is effective for the final judgment.14.
The details of the biological test methods may bechanged insofar as
they do not affect the essentialqualities of the test.15. The
temperature for the tests or storage isdescribed, in principle, in
specific figures. However,the following expressions may be used
instead.
Standard temperature, ordinary temperature, roomtemperature, and
lukewarm are defined as 209C, 15 259C, 1 309C, and 30 409C,
respectively. A coldplace, unless otherwise specified, shall be a
placehaving a temperature of 1 159C.
The temperature of cold water, lukewarm water,warm water, and
hot water are defined as not exceed-ing 109C, 30 409C, 60 709C, and
about 1009C,respectively.
The term ``heated solvent'' or ``hot solvent'' meansa solvent
heated almost to the boiling point of thesolvent, and the term
``warmed solvent'' or ``warmsolvent'' usually means a solvent
heated to a tempera-ture between 609C and 709C. The term ``heat on
or ina water bath'' indicates, unless otherwise specified,heating
with a boiling water bath or a steam bath atabout 1009C.
Cold extraction and warm extraction are usuallyperformed at
temperatures of 15 259C and 35 459C, respectively.16. To measure
the number of drops, a droppingdevice which delivers 20 drops of
water weighing0.90 1.10 g at 209C shall be used.17. The term ``in
vacuum'' indicates, unlessotherwise specified, a pressure not
exceeding 2.0 kPa.18. The acidity or alkalinity of a solution,
unlessotherwise specified, is determined by blue or red lit-mus
papers. To indicate these properties more pre-
cisely, pH values are used.19. The terms in Table 1 are used to
express thedegree of cutting of Crude Drugs or fineness of pow-der
Drugs.
20. The water to be used in the tests of drugs shall bethe water
suitable for performing the relevant test,such as the water not
containing any substance thatwould interfere with the test.21. As
for wording ``solution of a solute'', where thename of the solvent
is not stated, the term ``solution''indicates a solution in
water.22. For solution an expression such as ``(1 in 3)'',``(1 in
10)'', or ``(1 in 100)'' means that 1 g of a solid isdissolved in,
or 1 mL of a liquid is diluted with thesolvent to make the total
volume of 3 mL, 10 mL or100 mL, respectively. For the liquid
mixture anexpression such as ``(10:1)'' or ``(5:3:1)'' means
thatthe respective numbers of parts, by volume, of thedesignated
liquids are to be mixed.23. The term ``weigh accurately'' means to
weighdown to the degree of 0.1 mg, 0.01 mg or 0.001 mg bytaking
into account the purpose of the test and using arelevant weighing
device. The term ``weigh exactly''means to weigh to the given
decimal places.24. A value of ``n'' figures in a test of a JP
Drugshall be obtained by rounding off a value of ``n 1''figures.25.
Unless otherwise specified, all tests of the drugsshall be
performed at the ordinary temperature andobservations of the
results shall follow immediatelyafter the operations. However, the
judgment for a testwhich is affected by temperature should be based
onthe conditions at the standard temperature.26. The terms
``immediately''/``at once'' used in thetest of a JP Drug mean that
the procedure is to be per-formed within 30 seconds after the
precedingprocedure.27. In the section under the heading
Description, theterm ``white'' is used to indicate white or
practicallywhite, and ``colorless'' is colorless or practically
color-less. Unless otherwise specified, the test of color is
car-ried out by placing 1 g of a solid drug on a sheet of
-
3
Table 2
Descriptive term Volume of solvent requiredfor dissolving1 g or
1 mL of solute
Very soluble Less than 1 mLFreely soluble From 1 mL to less than
10
mLSoluble From 10 mL to less than 30
mLSparingly soluble From 30 mL to less than 100
mLSlightly soluble From 100 mL to less than
1000 mLVery slightly soluble From 1000 mL to less than
10000 mLPractically insoluble, or insolu-ble
10000 mL and over
3JP XVI General Notices
white paper or in a watch glass placed on white paper.A liquid
drug is put into a colorless test tube of 15-mminternal diameter
and is observed in front of a whitebackground through a layer of 30
mm. For the test ofclarity of liquid drugs the same procedure is
appliedwith either a black or white background. For theobservation
of fluorescence of a liquid drug, only ablack background shall be
used.28. In the section under the heading Description, theterm
``odorless'' is used to indicate odorless or practi-cally odorless.
Unless otherwise specified, the test ofodor shall be carried out by
placing 1 g of a solid drugor 1 mL of a liquid drug in a beaker.29.
In the section under the heading Description,solubilities are
expressed by the terms in Table 2.Unless otherwise specified,
solubility means the degreeof dissolution of a JP Drug, previously
powdered inthe case of a solid drug, within 30 minutes in a
solventat 20 59C, by vigorous shaking for 30 seconds eachtime at
5-minute intervals.
30. In the test of a drug, the term ``dissolve'' or``miscible''
indicates that it dissolves in, or mixes inarbitrary proportion
with the solvent to form a clearsolution or mixture. Insoluble
materials other than thedrug including fibers should not be
detected or practi-cally invisible, if any.31. Identification is
the test to identify the activeingredient(s) of the drug based upon
its specificproperty.32. Purity is the test to detect
impurities/con-taminants in drugs, and it, as well as other
require-ments in each monograph, specifies the purity of thedrug
usually by limiting the kind/nature and quantityof the
impurities/contaminants. The impurities/contaminants subject to the
purity test are those sup-posed to generate/contaminate during the
manufac-turing process or storage, including hazardous agents
such as heavy metals, arsenic, etc. If any foreign sub-stances
are used or supposed to be added, it is neces-sary to perform tests
to detect or limit the presence ofsuch substances.33. The term
``constant mass'' in drying or ignition,unless otherwise specified,
means that the mass differ-ence after an additional 1 hour of
drying or ignition isnot more than 0.10z of the preceding mass of
thedried substance or ignited residue. For crude drugs,the
difference is not more than 0.25z. However,when the difference does
not exceed 0.5 mg in a chemi-cal balance, 0.05 mg in a
semi-microbalance, or 0.005mg in a microbalance, the constant mass
has been at-tained.34. Assay is the test to determine the
composition,the content of the active ingredients, and the
potencyunit of medicine by physical, chemical or
biologicalprocedures.35. In stating the appropriate quantities to
be takenfor assay, the use of the word ``about'' indicates
aquantity within 10z of the specified mass. The word``dry'' in
respect of the sample indicates drying underthe same conditions, as
described in Loss on drying inthe monograph.36. For the content of
an ingredient determined byAssay in the monographs, if it is
expressed simply as``not less than a certain percentage'' without
indicat-ing its upper limit, 101.0z is understood as the
upperlimit.37. The container is the device which holds drugs.The
stopper or cap, etc., is considered as part of thecontainer. The
containers have no physical and chemi-cal reactivity affecting the
specified description andquality of the contents.38. A well-closed
container protects the contentsfrom extraneous solids and from loss
of the drugunder ordinary or customary conditions of
handling,shipment, and storage.
Where a well-closed container is specified, it may bereplaced by
a tight container.39. A tight container protects the contents
fromextraneous solids or liquids, from loss of the contents,and
from efflorescence, deliquescence, or evaporationunder ordinary or
customary conditions of handling,shipment, and storage.
Where a tight container is specified, it may bereplaced by a
hermetic container.40. A hermetic container is impervious to air or
anyother gas under ordinary or customary conditions ofhandling,
shipment, and storage.41. The term ``light-resistant'' means that
it can pre-vent transmittance of light affecting in the
specifiedproperties and quality of the contents and protect the
-
4
AbbreviationsCS: Colorimetric Stock SolutionRS: Reference
StandardTS: Test SolutionVS: Refer to a solution listed in Standard
Solutions for Volumetric Analysis .
4 JP XVIGeneral Notices
contained medicament from the light under ordinaryor customary
conditions of handling, shipment, andstorage.42. For the JP Drugs,
the contents or potency interms of units of the active
ingredient(s), or the speci-fied expiration date in the monographs
have to beshown on the immediate container or wrapping ofthem.43.
The origin, numerical value or physical proper-ties of the JP
Drugs, being stipulated by the special
labeling requirements in the monographs, have to beshown on the
immediate container or wrapping ofthem.44. The harmonized General
Tests and Monographsamong the Japanese Pharmacopoeia, the
EuropeanPharmacopoeia and the United States Pharmacopeiaare
preceded by the statement as such.
The parts of the text, being not harmonized, aresurrounded by
the symbols ( ).
-
55
GENERAL RULESFOR CRUDE DRUGS
1. Crude drugs in the monographs include medicinalparts obtained
from plants or animals, cell inclusionsand secretes separated from
the origins, their extracts,and minerals. General Rules for Crude
Drugs andCrude Drugs Test are applicable to the following:
Acacia, Achyranthes Root, Agar, Akebia Stem,Alisma Rhizome,
Aloe, Alpinia Officinarum Rhi-zome, Aluminum Silicate Hydrate with
Silicon Diox-ide, Amomum Seed, Anemarrhena Rhizome,
AngelicaDahurica Root, Apricot Kernel, Aralia Rhizome,Areca,
Artemisia Capillaris Flower, Asiasarum Root,Asparagus Tuber,
Astragalus Root, AtractylodesLancea Rhizome, Atractylodes Rhizome,
Bear Bile,Bearberry Leaf, Belladonna Root, Benincasa Seed,Benzoin,
Bitter Cardamon, Bitter Orange Peel, BrownRice, Bupleurum Root,
Burdock Fruit, Calumba,Capsicum, Cardamon, Cassia Seed, Catalpa
Fruit,Chrysanthemum Flower, Cimicifuga Rhizome, Cinna-mon Bark,
Citrus Unshiu Peel, Clematis Root, Clove,Cnidium Monnieri Fruit,
Cnidium Rhizome, CoixSeed, Condurango, Coptis Rhizome, Cornus
Fruit,Corydalis Tuber, Crataegus Fruit, Cyperus Rhizome,Digenea,
Dioscorea Rhizome, Dolichos Seed,Eleutherococcus Senticosus
Rhizome, Ephedra Herb,Epimedium Herb, Eucommia Bark, Euodia
Fruit,Fennel, Forsythia Fruit, Fritillaria Bulb, Gambir,Gardenia
Fruit, Gastrodia Tuber, Gentian, GeraniumHerb, Ginger, Ginseng,
Glehnia Root and Rhizome,Glycyrrhiza, Gypsum, Hemp Fruit, Honey,
Hout-tuynia Herb, Immature Orange, Imperata Rhizome,Ipecac,
Japanese Angelica Root, Japanese Gentian,Japanese Valerian, Jujube,
Jujube Seed, Koi, Leonu-rus Herb, Lilium Bulb, Lindera Root,
LithospermumRoot, Longan Aril, Longgu, Lonicera Leaf and
Stem,Loquat Leaf, Lycium Bark, Lycium Fruit, MagnoliaBark, Magnolia
Flower, Mallotus Bark, Mentha Herb,Moutan Bark, Mulberry Bark,
Nelumbo Seed, Notop-terygium, Nuphar Rhizome, Nutmeg, Nux
Vomica,Ophiopogon Tuber, Oriental Bezoar, Oyster Shell,Panax
Japonicus Rhizome, Peach Kernel, PeonyRoot, Perilla Herb,
Peucedanum Root, PharbitisSeed, Phellodendron Bark, Picrasma Wood,
PinelliaTuber, Plantago Herb, Plantago Seed, PlatycodonRoot,
Pogostemon Herb, Polygala Root, Polygona-tum Rhizome, Polygonum
Root, Polyporus Scleroti-
um, Poria Sclerotium, Powdered Acacia, PowderedAgar, Powdered
Alisma Rhizome, Powdered Aloe,Powdered Amomum Seed, Powdered
AtractylodesLancea Rhizome, Powdered Atractylodes Rhizome,Powdered
Calumba, Powdered Capsicum, PowderedCinnamon Bark, Powdered Clove,
Powdered CnidiumRhizome, Powdered Coix Seed, Powdered Coptis
Rhi-zome, Powdered Corydalis Tuber, Powdered CyperusRhizome,
Powdered Dioscorea Rhizome, PowderedFennel, Powdered Gambir,
Powdered Gardenia Fruit,Powdered Gentian, Powdered Geranium Herb,
Pow-dered Ginger, Powdered Ginseng, Powdered Glycyr-rhiza, Powdered
Ipecac, Powdered Japanese AngelicaRoot, Powdered Japanese Gentian,
PowderedJapanese Valerian, Powdered Longgu, PowderedMagnolia Bark,
Powdered Moutan Bark, PowderedOyster Shell, Powdered Panax
Japonicus Rhizome,Powdered Peach Kernel, Powdered Peony
Root,Powdered Phellodendron Bark, Powdered PicrasmaWood, Powdered
Platycodon Root, Powdered Polyg-ala Root, Powdered Polypourus
Sclerotium, PowderdPoria Sclerotium, Powdered Processed Aconite
Root,Powdered Rhubarb, Powdered Rose Fruit, PowderedScutellaria
Root, Powdered Senega, Powdered SennaLeaf, Powdered Smilax Rhizome,
Powdered SophoraRoot, Powdered Sweet Hydrangea Leaf,
PowderedSwertia Herb, Powdered Tragacanth, PowderedTurmeric,
Powdered Zanthoxylum Fruit, ProcessedAconite Root, Processed
Ginger, Prunella Spike,Pueraria Root, Quercus Bark, Red Ginseng,
Rehman-nia Root, Rhubarb, Rose Fruit, Rosin, Royal Jelly,Safflower,
Saffron, Saposhnikovia Root and Rhi-zome, Sappan Wood, Saussurea
Root, SchisandraFruit, Schizonepeta Spike, Scopolia Rhizome,
Scutel-laria Root, Senega, Senna Leaf, Sesame, SinomeniumStem and
Rhizome, Smilax Rhizome, Sophora Root,Sweet Hydrangea Leaf, Swertia
Herb, Toad Venom,Tragacanth, Tribulus Fruit, Trichosanthes Root,
Tur-meric, Uncaria Hook, Zanthoxylum Fruit, Zedoary.2. Crude drugs
are usually used in the forms ofwhole crude drugs, cut crude drugs
or powdered crudedrugs.
Whole crude drugs are the medicinal parts or theiringredients
prepared by drying and/or simple proc-esses, as specified in the
monographs.
-
66 JP XVIGeneral Rules for Crude Drugs
Cut crude drugs are small pieces or small blocks pre-pared by
cutting or crushing of the whole crude drugs,and also coarse,
medium or fine cutting of the crudedrugs in whole, and, unless
otherwise specified, arerequired to conform to the specifications
of the wholecrude drugs used as original materials.
Powdered crude drugs are coarse, medium, fine orvery fine powder
prepared from the whole crude drugsor the cut crude drugs; usually
powdered crude drugsas fine powder are specified in the
monographs.3. Unless otherwise specified, crude drugs are used
indried form. The drying is usually carried out at a tem-perature
not exceeding 609C.4. The origin of crude drugs is to serve as
thecriteria. Such statements as `other species of the samegenus'
and `allied plants' or `allied animals' appearingin the origin of
crude drugs usually indicate plants oranimals which may be used as
materials for crudedrugs containing the same effective
constituents.5. Description in each monograph for crude
drugsusually covers the crude drug derived from its typicaloriginal
plant or animal and includes statements ofcharacteristic properties
of the crude drug. As for thecolor, odor and solubility, apply
correspondingly tothe prescription of the General Notices, except
the
odor which is to serve as the criteria. The taste andaspects
obtained by microscopic observation are toserve as the criteria.6.
Powdered crude drugs, otherwise specified, maybe mixed with
diluents so as to attain proper contentand potency.7. Powdered
crude drugs do not contain fragmentsof tissues, cells, cell
inclusions or other foreign matteralien to the original crude drugs
or cut crude drugs.8. Crude drugs are as free as possible from
contami-nants and other impurities due to molds, insects andother
animals and from other foreign matters, and arerequired to be kept
in a clean and hygienic state.9. Crude drugs are preserved under
protection frommoisture and insect damage, unless otherwise
spec-ified. In order to avoid insect damage, suitablefumigants may
be used to preserve crude drugs,provided that the fumigants are so
readily volatilizedas to be harmless at the usual dosage of the
crudedrugs, and such fumigants that may affect the ther-apeutic
efficacy of the crude drugs or interfere withthe testing are
precluded.10. Crude drugs are preserved in well-closed contain-ers
unless otherwise specified.
-
77
GENERAL RULESFOR PREPARATIONS
[1] General Notices for Preparations
(1) General Notices for Preparations present gen-eral rules for
pharmaceutical dosage forms.
(2) In [2] Monographs for Preparations, dosageforms are
classified mainly by administration routesand application sites,
and furthermore are subdividedaccording to their forms, functions
and characteris-tics.
Those preparations containing mainly crude drugsas active raw
materials are described under [3] Mono-graphs for Preparations
Related to Crude Drugs.
(3) In Monographs for Preparations and Mono-graphs for
Preparations Related to Crude Drugs,dosage forms, which are
generally or widely used, aredescribed. However, any other
appropriate dosageforms may be used where appropriate. For example,
adosage form suitable for a particular application maybe designated
by combining an administration routeand a name of a dosage form
listed in these chapters.
(4) In these monographs, preparation characteris-tics are
specified for the dosage forms. The prepara-tion characteristics
are confirmed by appropriate tests.
(5) In the case of preparations, functions that con-trol the
release rate of active substance(s) may be ad-ded for the purpose
of controlling the onset and dura-tion of therapeutic effects
and/or decreasing adverseor side effects. The preparations modified
in releaserate must have an appropriate function of
controlledrelease for the intended use. The added
functionalmodification must generally be displayed on the
packinsert and on the direct container or packaging ofthese
preparations.
(6) Pharmaceutical excipients are substances otherthan active
substances contained in preparations, andthey are used to increase
the utility of the activesubstance(s) and preparation, to make
formulationprocess easier, to keep the product quality, to
improvethe usability, and so forth. Suitable excipients may beadded
for these purposes. The excipients to be used,however, must be
pharmacologically inactive andharmless in the administered amount
and must notinterfere with the therapeutic efficacy of the
prepara-tions.
(7) Purified water to be used for preparations isPurified Water
or Purified Water in Containers, andwater for injection is Water
for Injection or Water forInjection in Containers.
Vegetable oils to be used for preparations are usu-ally edible
oils listed in the Pharmacopoeia. Whenstarch is called for, unless
otherwise specified, anykind of starch listed in the Pharmacopoeia
may beused.
In addition, ethanol specified in volz is preparedby adding
Purified Water or Water for Injection toethanol at the specified
volz.
(8) Even non-sterile preparations should be pre-pared with
precautions to prevent contamination andgrowth of microorganisms,
and they are applied to thetest of Microbial Limit Test , if
necessary.
(9) The test for Content Uniformity under theUniformity of
Dosage Units and the Dissolu-tion Test are not intended to apply to
the crudedrug component of preparations which are preparedusing
crude drugs or preparations related to crudedrugs as raw
materials.
(10) Containers and packaging for preparationsmust be suitable
for their proper use and for ensuringsafe application, as well as
for maintaining the qualityof the preparations. To protect
preparations that maybe susceptible to oxygen in the air,
deoxidants or con-tainers made of low-gas-permeability material may
beused. For preparations susceptible to degradation bymoisture,
packages with desiccants or moisture-proofpackaging using
low-moisture-permeability materialsfor containers may be used. For
preparations suscepti-ble to degradation by evaporation of water,
containersof low-moisture-permeability material may be used.
Preparations for single-dose use are referred to
as``preparations in single-dose packages''.
(11) Unless otherwise specified, preserve prepara-tions at room
temperature. Store them in light-resistant containers or packaging,
if light affects thequality of the preparation.
-
88 JP XVIMonographs for Preparations / General Rules for
Preparations
[2] Monographs for Preparations
(1) In the Monographs for Preparations, the defi-nitions of
dosage forms, manufacturing methods,test methods, containers and
packaging, and storageare described.
(2) The descriptions of the test methods and thecontainers and
packaging in these monographs arefundamental requirements, and the
manufacturingmethods represent commonly used methods.
1. Preparations for Oral Administration(1) Immediate-release
dosage forms are prepara-
tions showing a release pattern of active substance(s)that is
not intentionally modified and is generally de-pendent on the
intrinsic solubility of the active sub-stance.
(2) Modified-release dosage forms are prepara-tions showing a
release pattern of active substance(s)that is suitably modified for
the desired purpose bymeans of a specific formulation design
and/ormanufacturing method. Modified-release dosageforms include
enteric-coated and extended-releasepreparations.
(i) Enteric-coated (delayed-release) preparationsEnteric-coated
preparations are designed to
release the bulk of the active substance(s) not instomach but
mainly in small intestine, in order toprevent degradation or
decomposition of the activesubstance(s) in stomach or to decrease
the irritationof the active substance(s) on stomach. Enteric-coated
preparations are generally coated with anacid-insoluble enteric
film.
(ii) Extended-release preparationsExtended-release preparations
are designed to
control the release rate and release period of
activesubstance(s) and to restrict the release to appropri-ate
sites in the gastrointestinal tracts in order todecrease the dosing
frequency and/or to reduce ad-verse or side effects.
Extended-release preparationsare generally prepared by using
suitable agents thatprolong the release of the active
substance(s).(3) Oral dosage forms such as capsules, granules
and tablets can be coated with appropriate coatingagents, such
as sugars, sugar alcohols, or polymers,for the purpose of enabling
the ingestion easy or ofpreventing degradation of the active
substance(s).
1-1. Tablets(1) Tablets are solid preparations having a
desired
shape and size, intended for oral administration.Orally
Disintegrating Tablets, Chewable Tablets,
Effervescent Tablets, Dispersible Tablets and SolubleTablets are
included in this category.
(2) Tablets are usually prepared by the followingprocedures.
Enteric-coated or extended-release tabletscan be prepared by
appropriate methods.
(i) Mix homogeneously active substance(s) andexcipients such as
diluents, binders and disintegra-tors, granulate with water or a
binder solution by asuitable method, mix with a lubricant, and
thencompress into a desired shape and size.
(ii) Mix homogeneously active substance(s) andexcipients such as
diluents, binders, and disintegra-tors, and then directly compress
with a lubricant, orcompress after adding active substance(s) and
alubricant to granules previously prepared from ex-cipients and
then mixing homogeneously.
(iii) Mix homogeneously active substance(s) andexcipients such
as diluents and binders, moisten witha solvent, form into a certain
shape and size or moldthe mixed mass into a certain shape and size,
andthen dry by a suitable method.
(iv) Plain Tablets are usually prepared accordingto (i), (ii) or
(iii).
(v) Film-coated Tablets can be prepared, usu-ally, by coating
Plain Tablets with thin films usingsuitable film coating agents
such as polymers.
(vi) Sugar-coated Tablets can be prepared, usu-ally, by coating
Plain Tablets using suitable coatingagents including sugars or
sugar alcohols.
(vii) Multiple-layer Tablets can be prepared bycompressing
granules of different compositions toform layered tablets by a
suitable method.
(viii) Pressure-coated Tablets can be preparedby compressing
granules to cover inner core tabletswith different compositions.(3)
Unless otherwise specified, Tablets meet the
requirements of Uniformity of Dosage Units .(4) Unless otherwise
specified, Tablets meet the
requirements of Dissolution Test or Disintegra-tion Test . For
Effervescent tablets from whichactive substance(s) are dissolved
before use and Solu-ble tablets, these tests are not required.
(5) Well-closed containers are usually used for thepreparations.
For preparations susceptible to degrada-tion by moisture, a
moisture-proof container or pack-aging may be used.
1-1-1. Orally Disintegrating Tablets/Orodispersi-ble Tablets
(1) Orally Disintegrating Tablets are tablets whichare quickly
dissolved or disintegrated in the oralcavity.
(2) Orally Disintegrating Tablets shows an appro-priate
disintegration.
-
99JP XVI General Rules for Preparations / Monographs for
Preparations
1-1-2. Chewable Tablets(1) Chewable Tablets are tablets which
are admin-
istered by chewing.(2) Chewable Tablets must be in shape and
size
avoiding danger of suffocation.1-1-3. Effervescent Tablets(1)
Effervescent Tablets are tablets which are
quickly dissolved or dispersed with bubbles in water.(2)
Effervescent tablets are usually prepared using
suitable acidic substances and carbonates or
hydrogencarbonates.
1-1-4. Dispersible Tablets(1) Dispersible Tablets are tablets
which are ad-
ministered after having been dispersed in water.1-1-5. Soluble
Tablets(1) Soluble Tablets are tablets which are adminis-
tered after having been dissolved in water.
1-2. Capsules(1) Capsules are preparations enclosed in
capsules
or wrapped with capsule bases, intended for oral
ad-ministration. Capsules are classified into Hard Cap-sules and
Soft Capsules.
(2) Capsules are usually prepared by the followingmethods.
Enteric-coated or extended-release capsulescan be prepared by a
suitable method. Coloringagents, preservatives, etc. may be added
to the capsulebases.
(i) Hard Capsules: A homogeneous mixture ofactive substance(s)
with diluents and other suitableexcipients, or granules or formed
masses preparedby a suitable method, are filled into capsule shells
asthey are or after slight compression.
(ii) Soft Capsules: Active substance(s) and suita-ble excipients
(including solvents) are mixed, en-closed by a suitable capsule
base such as gelatinplasticized by addition of glycerin,
D-sorbitol, etc.and molded in a suitable shape and size.(3) Unless
otherwise specified, Capsules meet the
requirements of Uniformity of Dosage Units .(4) Unless otherwise
specified, Capsules meet the
requirements of Dissolution Test or Disintegra-tion Test .
(5) Well-closed containers are usually used forCapsules. For
Capsules susceptible to degradation bymoisture, a moisture-proof
container or packagingmay be used.
1-3. Granules(1) Granules are preparations prepared by
granula-
tion, intended for oral administration. EffervescentGranules are
included in this category.
(2) Granules are usually prepared by the following
methods. Granules can be coated using suitable coat-ing agents
if necessary. Extended-release or enteric-coated granules can also
be prepared by a suitablemethod.
(i) To powdery active substance(s) add diluents,binders,
disintegrators, or other suitable excipients,mix to homogenize, and
granulate by a suitablemethod.
(ii) To previously granulated active substance(s)add excipients
such as diluents, and mix tohomogenize.
(iii) To previously granulated active substance(s)add excipients
such as diluents, and granulate by asuitable method.(3) Among
Granules, the preparations may be
referred to as ``Fine Granules'' if, when Particle
SizeDistribution Test for Preparations is per-formed, all granules
pass through a No. 18 (850 mm)sieve, and not more than 10z of which
remain on aNo. 30 (500 mm) sieve.
(4) Unless otherwise specified, the Granules insingle-dose
packages meet the requirements of Unifor-mity of Dosage Units .
(5) Unless otherwise specified, Granules complywith Dissolution
Test or Disintegration Test. However, this provision is not to be
applied toEffervescent granules, which are dissolved before use,and
Disintegration Test is not required for theGranules not more than
10z of which remain on aNo. 30 (500 mm) sieve when the test is
performed asdirected under Particle Size Distribution Test
forPreparations .
(6) Among Granules, the particulate preparationsmay be referred
to as ``Powders'' if, when the ParticleSize Distribution Test for
Preparations is per-formed, all granules pass through a No. 18 (850
mm)sieve, and not more than 5z remain on a No. 30 (500mm)
sieve.
(7) Well-closed containers are usually used forGranules. For the
preparations susceptible to degrada-tion by moisture, a
moisture-proof container or pack-aging may be used.
1-3-1. Effervescent Granules(1) Effervescent granules are
granules which are
quickly dissolved or dispersed with bubbles in water.(2)
Effervescent granules are usually prepared
using suitable acidic substances and carbonates orhydrogen
carbonates.
1-4. Powders(1) Powders are preparations in powder form, in-
tended for oral administration.(2) Powders are usually prepared
by homogene-
-
1010 JP XVIMonographs for Preparations / General Rules for
Preparations
ously mixing active substance(s) with diluents or othersuitable
excipients.
(3) Unless otherwise specified, the Powders insingle-dose
packages meet the requirements of Unifor-mity of Dosage Units .
(4) Unless otherwise specified, Powders meet therequirements of
Dissolution Test .
(5) Well-closed containers are usually used forPowders. For the
preparations susceptible to degrada-tion by moisture, a
moisture-proof container or pack-aging may be used.
1-5. Liquids and Solutions for Oral Administration(1) Liquids
and Solutions for Oral Administration
are preparations in liquid form or flowable and vis-cous
gelatinous state, intended for oral administra-tion. Elixirs,
Suspensions, Emulsions and Lemonadesare included in this
category.
(2) Liquids and Solutions for Oral Administrationare usually
prepared by dissolving, emulsifying or sus-pending active
substance(s) in Purified Water togetherwith excipients, and by
filtering if necessary.
(3) For Liquids and Solutions for Oral Adminis-tration which are
apt to deteriorate, prepare beforeuse.
(4) Unless otherwise specified, the preparations insingle-dose
packages meet the requirement of Unifor-mity of Dosage Units .
(5) Tight containers are usually used for Liquidsand Solutions
for Oral Administration. For the prepa-rations susceptible to
degradation by evaporation ofwater, a low-moisture-permeability
container or pack-aging may be used.
1-5-1. Elixirs(1) Elixirs are clear, sweetened and aromatic
liquid
preparations, containing ethanol, intended for oral
ad-ministration.
(2) Elixirs are usually prepared by dissolving solidactive
substance(s) or their extractives in ethanol andPurified Water,
adding aromatic agents and sucrose,other sugars or sweetening
agents, and clarifying byfiltration or other procedure.
1-5-2. Suspensions(1) Suspensions are liquid preparations of
active
substance(s) suspended finely and homogeneously in avehicle,
intended for oral administration.
(2) Suspensions are usually prepared by addingsuspending agent
or other suitable excipients and Puri-fied Water or oil to solid
active substance(s), and sus-pending homogeneously as the whole by
a suitablemethod.
(3) Mix homogeneously before use, if necessary.(4) Unless
otherwise specified, Suspensions meet
the requirements of Dissolution Test .1-5-3. Emulsions(1)
Emulsions are liq