Monograph devlopement manish

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INDIAN PHARMACOPOEIA

Monograph Development

Prepared By,

Manish MudaliarM.Pharm,Semester-IIIDept. of QARA

Seminar on,

LJ Institute of pharmacy

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Indian Pharmacopoeia Commission (IPC)

•Vision

▫The IPC is committed to the promotion of the

highest standards for drugs for use in the

prevention and treatment of diseases in human

beings and animals keeping in view the special

features of the pharmaceutical industry in India.

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INDIAN PHARMACOPOEIAMONOGRAPH DEVELOPMENT

•Objectives:▫ The overall objective has been the creation of a

compilation of standards that reflect the state of the industry in the country and the production and testing capabilities of units varying in size from the small to the very big.

▫Special efforts have been made to safeguard the interests of the weaker sectors of the industry without compromising the safety and efficacy of the medicines included in the Indian Pharmacopoeia (IP).

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Features:

• Priority is given to monographs of drugs included in the

National Essential Drugs List and their dosage forms

• Regular up-gradation of monographs but consistent with

the level and degree of sophistication acceptable to the

majority of manufacturers.

• Harmonization of IP standards with international

acceptance criteria for drug quality

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Quality Standards:

Following points should be under consideration during setting of standards:

•Neither high nor low

•Should not be avoidance of sophisticated

instrumentation or methodology

•Recognition of the difficulties of the small- and

medium sized units of the industry

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Quality Standards cont… :

•Retention of simple tests where complicated methods

offer no advantage

•No compromise on limitation of toxic impurities

•Gradual tightening of standards over the years

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Overall philosophy:

• The Indian Pharmacopoeia is the official book of

standards and medicines produced in India must

comply with the specified standards.

• Pharmacopoeial standards and acceptance criteria are

set with the intention that they should be used only as

compliance requirements and not as requirements to

guarantee total quality assurance.

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Overall philosophy cont…:

• Pharmacopoeial standards are the minimum ones with which a

manufacturer must comply before release of a product for sale

or distribution

• It is recognized that changes in quality may occur during

storage and distribution and the Pharmacopoeial requirements

are set to define acceptable levels of change and to reject

materials or products showing unacceptable levels

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Overall philosophy cont…:

• It is the responsibility of the manufacturer to ensure

that the product is manufactured in accordance with

current Good Manufacturing Practices.

• Pharmacopoeial requirements for drug substances have

been drawn up to provide appropriate limits for

potential impurities rather than to provide against all

possible impurities and adulterants.

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Contents of the Pharmacopoeia •The technical part of the pharmacopoeia shall be

broadly divided into the following sections:

1. Introduction 2. General Notices 3. Monographs 4. Test methods 5. Reagents and Solutions 6. General Texts 7. Index

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Formats and Contents of Monographs

1. A one-column format shall be used for all the pages of the monographs.

2. The font shall be Arial and the size for the text matter shall be 10 pt.

3. Reagents, buffer solutions, chemicals other substances that are described or defined in the Pharmacopoeia shall be in italics.

4. Italic types shall also be used for the systematic names of plants and micro- organisms, and for some sub-headings of tests and texts and for some parts of the chemical names.

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5. Titles of monographs and headings of tests must be began with capital letters in bold letters and aligned on the left with the text. Synonyms, if any, shall be printed two spaces below the main title and shall not be in bold letters.

6. Single-line spacing shall be followed and the alignment of the text of the monograph shall be ‘justified’. Each test parameter and the accompanying text shall be separated from the other by a space of 1.5 lines.

7. Given in the following pages are directions on the manner in which the various tests and assays are to be described. Where the instructions are in red, the texts shall appear in the monographs in exactly the same way as shown.

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A. Active Pharmaceutical Ingredients (APIs) (Bulk Drug Substances) Chemical Excipients

1. Title of the Monograph • Name of the item in bold letters in font Arial size 12 pt. The INN

approved by the WHO shall be used. • Synonym shown below the main title (in ordinary letters) The main

monograph headings viz. Identification and Tests etc. shall be in Arial size 11 pt, and the headings of the individual tests in size 10 pt, and all in bold letters

e.g. Sodium Aminosalicylate Sodium PAS

2. Formula • Structural (Graphic) Formula • The molecular formula on the left and the molecular weight expressed to

one decimal place on the right, two spaces below the graphic formula.

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3. Chemical name: Ethionamide is 2-ethylpyridine-4-carbothioamide.

4. Statement of purity: Ethionamide contains not less than 98.5 per cent and not more than 101.0 per cent of C8H10N2S, calculated on the dried basis.

5. Description: A pale yellow oil with slight, but not rancid odour.

6. Identification: The tests shall be marked with the letters A, B, C and so on followed by a dot and then the text after one space.

e.g. A. Determine by infrared absorption spectropho tometry (2.2.40). Compare the spectrum with that obtained with ceftazidime RS or with the reference spectrum of ceftazidime.

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7. Appearance of solution: The solution is clear and not more intensely coloured than reference solution.

8. pH 9. Specific optical rotation 10. Light-absorbing impurities : The absorbance (2.2.25)

of the resulting solution, determined at 495 nm is not more than 0.07 calculated on the dried basis.

11. Related substances: Details of the method-usually by thin-layer, or liquid chromatography or gas chromatography shall be given.

12. Arsenic: Method of preparing the test solution shall be given. The resulting solution complies with the limit test for arsenic.

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13.Heavy metals 14.Iron 15.Chlorides 16.Sulphates 17.Non-volatile substances 18.Residual solvents: Determine by head-space gas

chromatography. 19.Microbial contamination: Determined by plate

count. 20.Bacterial Endotoxins 21.Sterility: It complies with the test for sterility.

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22. Pyrogens

23. Sulphated ash: Not more than 0.1 per cent, determined on 2.0 g

24. Water

25. Loss on drying: Not more than 1.0 per cent, determined on 5.0 g by

drying in an oven at 100° to 105°.

26. Assay: Determine by liquid chromatography

• Test solution. Directions for preparing to be given

• Reference solution. – do –

• Chromatographic system:

• Details of the column,

• Mobile phase composition and flow rate,

• Detector and wavelength setting,

• Injection device (if any), and

• Any other detail.

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27.Storage: Store at a temperature not exceeding 30°. If the substance is sterile, store in a sterile, airtight, tamper-proof container.

28.Labelling: Any special labelling statements specific to the product is given.

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B. Inactive Ingredients other than Chemicals, Drugs of Plant Origin

1. Title of the Monograph : Name in bold letters and font size 13pt.

2. Opening Statement: Must define the article e.g. Activated Charcoal is obtained from vegetable matter by

suitable carbonisation processes intended to confer a high adsorbing power.

3. Description, Identification and other tests, including Assay 4. Relative density 5. Weight per ml 6. Refractive index7. Melting point8. Freezing point: Not less than xxx°

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9. Viscosity: x mPa.s to y mPa.s 10. Peroxide value, Acid value, Ester value11. Unsaponi-fiable matter, Acetyl value, Hydroxyl value,

Saponi-fication value 12. Iodine value 13. Acidity 14. Foreign matter, Total ash, Ash insoluble in hydrochloric

acid 15. Storage 16. Labelling

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C. Dosage Forms

1. Title of the Monograph: Name in bold letters in font size 13 pt

2. Description: For parenteral preparations information shall be provided whether it is a solution, a suspension, a dry powder

3. Content statement 4. Identification 5. Related substances/ Impurities: Tests for related

substances or impurities arising on manufacture or storage of the dosage form shall be included.

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6. Specific tests: For Aspirin Tablets: Salicylic acid.7. Disintegration 8. Dissolution 9. Assay 10.Storage 11.Labelling

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D. Vaccines, Immunosera and Products of Plant Origin

1. An opening statement that defines the preparation .2. Production. The details of the method of producing

the product shall be described.3. Identification. 4. Tests. Details of specific tests including sterility,

toxicity, potency or assay shall be given

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E. General Monographs on Dosage Forms

The dosage forms for which General Monographs may be written are as follows:

• Capsules • Ear preparations • Eye preparations • Granules • Liquids for oral use • Nasal Preparations • Parenteral preparations • Oral powders • Preparations for inhalation • Creams and Ointments • Rectal and vaginal preparations • Tablets .

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The General Monographs shall be generally in three sections:

A. General description or definition of the dosage form and its different types.

B. Specific aspects of production that impact on the quality of the product.

C. Tests to be done in addition to the ones set out in the individual monographs.

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Reference:

•Indian Pharmacopoeia 6, “Guide to Formats” by Indian Pharmacopoeial Commission.

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“Winners”are those who never

‘fail’ but

those who never ‘Quit’.