This document is posted to help you gain knowledge. Please leave a comment to let me know what you think about it! Share it to your friends and learn new things together.
Transcript
Code Product Unit
EPY0000055
EPY0000116
EPY0000500
EPY0000354
EPY0000427
EPA0040000
EPY0000359
Acamprosate calcium - Reference Spectrum
Acamprosate impurity A 3-aminopropane-1-sulphonic acid
Acarbose
Acarbose for identification
Acarbose for peak identification
Acebutolol hydrochloride
Acebutolol impurity B N-[3-acetyl-4-[(2RS)-2-hydroxy-3-[(1-methylethyl) amino]propoxy]phenyl]acetamide (diacetolol)
Acebutolol impurity C N-(3-acetyl-4-hydroxyphenyl)butanamide
Acebutolol impurity I N-[3-acetyl-4-[(2RS)-3-(ethylamino)-2-hydroxypropoxy]phenyl)butanamide
Aceclofenac - Reference Spectrum
Aceclofenac for peak identification
Aceclofenac impurity F benzyl[[[2-[(2,6-dichlorophenyl)amino]phenyl]acetyl]oxy]acetate
Aceclofenac impurity H [[[[[[[2-[(2,6-dichlorophenyl)amino]phenyl]acetyl]oxy]acetyl]oxy]acetyl]oxy]acetic acid
Acemetacin
Acemetacin impurity A 4-chlorobenzoic acid
Acemetacine impurity mixture
Acesulfame potassium
Acesulfame potassium impurity B 5-chloro-6-methyl-1,2,3-oxathiazin-4(3H)-one 2,2-dioxide
Acetazolamide
Acetazolamide for system suitability
Acetylcholine chloride
Acetylcysteine
Acetylcysteine impurity C N,N'-diacetyl-L-cystine
Acetylcysteine impurity D N,S-diacetyl-L-cysteine
ß-Acetyldigoxin β-Acetyldigoxin for peak identification
Acetylsalicylic acid
Acetylsulfadiazine
N-Acetyltryptophan
N-Acetyltyrosine
Acholeplasma laidlawii BRP
Aciclovir
Aciclovir for system suitability
Aciclovir for peak identification 1
Aciclovir for peak identification 2
Actaea racemosa HRS
Actaea racemosa for assay CRS
Acitretin
Actaea rasemosa dry extract for system suitability HRS
Adapalene
Adapalene impurity C 1-[2-(methyloxy)phenyl]tricyclo[3.3.1.1]decane
Adapalene for peak identification
Adenine
unit
50 mg
94.7 mg
10 mg
40 mg
50 mg
10 mg
EPY0000127
EPY0000128
EPY0000056
EPY0001094
EPY0000085
EPY0000086
EPY0000810
EPY0000811
EPY0000842
EPA0070000
EPA0070020
EPA0100000
EPY0001084
EPY0000002
EPA0150000
EPA0152000
EPA0153000
EPY0000565
EPY0000642
EPA0200000
New EPY0001462
EPA0208000
EPA0202000
EPY0000693
EPA0220000
EPY0001264
EPY0001271
EPY0001269
New EPY0001463
New EPY0001543
EPA0225000
New EPY0001464
EPY0001121
EPY0001120
EPY0001119
EPA0230000
20 mg
0.004 mg
unit
10 mg
20 mg
10 mg
100 mg
10 mg
0.06 mg
50 mg
50 mg
100 mg
0.0068 mg
50 mg
50 mg
10 mg
10 mg
50 mg
10 mg
15 mg
0.002 mg
125 mg
200 mg
1 mL
75 mg
10 mg
0.3 mg
0.004 mg
1200 mg
300 mg
100 mg
1200 mg
100 mg
6 mg
2.022 mg
50 mg
Edition 2012/2013 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. 251
Table of content
European Pharmacopoeia
Code Product Unit
EPA0230200
EPY0000110
EPY0000882
EPY0000883
EPA0300000
EPY0000740
EPY0000707
EPY0000728
EPA0325000
EPA0325100
EPA0325200
EPA0325450
EPA0325451
EPA1225000
EPA0325500
EPA0325800
EPY0000832
EPA0349000
EPA0350000
EPA0350010
EPA0350020
EPA0350030
EPA0350040
EPA0350050
EPA0351000
EPY0000235
EPY0000255
EPA0357000
EPA0360000
EPY0000054
EPY0000606
EPY0000843
EPY0000687
EPY0000595
EPY0000607
EPA0363000
EPA0363700
EPA0900000
EPA0365000
EPA0368000
New EPY0001467
EPA0365900
EPY0001117
EPA0370000
EPY0000020
Adenosine
Adipic acid
Adrenaline
Adrenaline with impurity F
Adrenaline tartrate
Adrenaline impurity mixture
Adrenaline tartrate with impurity A
Agnus castus fruit standardised dry extract
Alanine
Albendazole
Alcuronium chloride
Alfacalcidol
Alfacalcidol - Reference Spectrum
Alfadex
Alfentanil hydrochloride - Reference Spectrum
Alfuzosin hydrochloride
Alfuzosin for system suitability
Allantoin
Allopurinol
Allopurinol impurity A 5-amino-1H-pyrazole-4-carboxamide
Allopurinol impurity B 5-formylamino-1H-pyrazole-4-carboxamide
Allopurinol impurity C 5-(4H-1,2,4-triazol-4-yl)1H-pyrazole-4-carboxamide
Allopurinol impurity D ethyl 5-amino-1H-pyrazole-4-carboxylate
Allopurinol impurity E ethyl 5-(formylamino)-1H-pyrazole-4-carboxylate
Allylstrychnine bromide
Almagate
Almagate - Reference Spectrum
Alprazolam Controlled Substance
Alprenolol hydrochloride
Alprostadil
Altizide
Altizide impurity B 3-[(2,2-dimethoxyethyl)sulphanyl]prop-1-ene
Alverine citrate
Alverine for peak identification
Alverine impurity D N-(3-cyclohexylpropyl)-N-ethyl-3-phenylpropan-1-amine
Amantadine hydrochloride
Ambroxol hydrochloride
Amfetamine sulfate - Reference Spectrum
Amidotrizoic acid dihydrate
Amikacin
Amikacin impurity I (2S)-4-amino-2-hydroxybutanoic acid
Amikacin sulfate
Amikacin for system suitability
Amiloride hydrochloride
Amiloride impurity A methyl-3,5-diamino-6-chloropyrazine-2-carboxylate
Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.
50 mg
50 mg
5 mg
10 mg
100 mg
0.005 mg
15 mg
200 mg
60 mg
50 mg
50 mg
5 mg
unit
150 mg
unit
10 mg
10 mg
60 mg
100 mg
10 mg
10 mg
10 mg
10 mg
20 mg
10 mg
25 mg
unit
100 mg
100 mg
50 mg
150 mg
15 mg
5 mg
0.125 mg
10 mg
100 mg
125 mg
unit
100 mg
200 mg
20 mg
200 mg
10 mg
100 mg
10 mg
252 Edition 2012/2013
Table of content
European Pharmacopoeia
Code Product Unit
EPY0000173
EPA0420000
EPA0460000
EPA0496000
EPA0496005
4-Aminobenzoic acid
Aminocaproic acid
7-Aminodesacetoxycephalosporanic acid
Aminoglutethimide
Aminoglutethimide impurity A (3RS)-3-(3-aminophenyl)-3-ethylpiperidine-2,6-dione; (3-aminoglutethimide)
Aminoglutethimide impurity D 3,3'-[diazenediyldi(4,1-phenylene)]bis(3-ethylpiperidine-2,6-dione) (azoglutethimide)
Amiodarone hydrochloride
Amiodarone impurity D (2-butyl-benzofuran-3-yl)-(4-hydroxy-3,5-diiodophenyl)methanone
Amiodarone impurity E (2-butylbenzofuran-3-yl)(4-hydroxyphenyl)methanone
Amisulpride
Amisulpride impurity B 4-amino-N-[[(2RS )-1-ethylpyrrolidin-2-yl] methyl]-5-(ethyl sulphonyl)-2-hydroxybenzamide
Amitriptyline hydrochloride
Amlodipine besilate
Amlodipine for peak identification
Amlodipine impurity A 3-ethyl 5-methyl (4RS)-4-(2-chlorophenyl)-2-[[2-(1,3-dioxo-1,3-dihydro-2H-isoindol-2- yl)ethoxy]methyl]-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate
Amlodipine impurity B 3-ethyl 5-methyl (4RS)-4-(2-chlorophenyl)-6-methyl-2-[[2-[[2- (methylcarbamoyl)benzoyl]amino]ethoxy]methyl]-1,4-dihydropyridine-3,5-dicarboxylate
Amlodipine impurity G dimethyl 4-(2-chlorophenyl)-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylate
Ammonio methacrylate copolymer (type A) - Reference Spectrum
Ammonio methacrylate copolymer (type B) - Reference Spectrum
Amobarbital Controlled Substance
Amobarbital sodium Controlled Substance
Amoxicillin trihydrate
Amphotericin B
Amphotericin B for microbiological assay
Amphotericin B for peak identification
Ampicillin (anhydrous)
Ampicillin trihydrate
Amylmetacresol
Amylmetacresol for peak identification
Angelica dahuria root
Anhydrotetracycline hydrochloride
Antazoline hydrochloride
Apomorphine hydrochloride - Reference Spectrum
Apomorphine hydrochloride hemihydrate
Apomorphine impurity B (Morphine sulfate) (Morphinhemisulfat-Pentahemihydrat) Controlled Substance
Alpha-apo-oxytetracycline
Beta-apo-oxytetracycline
Aprotinin solution BRP
Aprotinin for system suitability
L-Arabinitol
Arbutin
Arginine
Arginine aspartate
Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.
60 mg
50 mg
20 mg
125 mg
20 mg
EPA0496020
EPA0575000
EPY0000129
EPY0000130
EPA0590000
EPA0590004
EPY0000563
EPY0000049
EPY0001067
EPY0001068
10 mg
100 mg
20 mg
20 mg
10 mg
10 mg
10 mg
150 mg
10 mg
10 mg
EPY0001069 10 mg
EPY0001070
EPY0000302
EPY0000303
EPA0650000
EPA0700000
EPA0800000
EPY0000005
EPY0001361
EPY0001014
EPA1000000
EPA1100000
EPY0001244
EPY0001245
EPY0001386
EPA1200000
EPA1210000
EPY0000172
EPY0001465
New EPY0001471
EPA1220000
EPA1230000
EPA1250000
EPY0001154
EPA1269000
EPY0000806
EPA1270000
EPY0000304
Edition 2012/2013
10 mg
unit
unit
500 mg
500 mg
100 mg
100 mg
100 mg
10 mg
250 mg
150 mg
285 mg
10 mg
160 mg
15 mg
50 mg
unit
15 mg
40 mg
20 mg
20 mg
0.5 mL
2.7 mg
10 mg
100 mg
50 mg
20 mg
253
Table of content
European Pharmacopoeia
Code Product Unit
EPA1271000
New EPY0001323
EPY0001185
EPY0001175
EPY0000079
EPY0000080
EPY0000081
Arginine hydrochloride
Aristolochia
Aristolochic acid I
Aristolochic acid for system suitability
Articaine hydrochloride
Articaine impurity A methyl3-[[2-(propylamino)acetyl]amino]-4-methylthiophene-2-carboxylate
Articaine impurity E methyl 4-methyl-3-[[(2RS)-2-[(1-methylethyl)amino]propanoyl] amino]thiophene-2-carboxylate
Ascorbic acid (Vitamin C)
Ascorbic acid impurity C D-sorbosonic acid
Ascorbic acid impurity D methyl D-xylo-hex-2-ulosonate (methyl D-sorbosonate)
Ascorbyl palmitate
Asparagine monohydrate
Aspartame
Aspartame impurity A 2-(5-benzyl-3,6-dioxopiperazin-2-yl)acetic acid (diketopiperazine)
Aspartic acid
Astragaloside IV
Atenolol
Atenolol for system suitability
Atorvastatine calcium trihydrate
Atorvastatin impurity A desfluoroatorvastatin
Atorvastatin impurity B 3-epi-atorvastatin
Atorvastatin impurity C fluoroatorvastatin
Atorvastatin impurity D 3-[(4-fluorophenyl)carbonyl]-2-(2-methylpropanoyl)-N,3-diphenyloxirane-2-carboxamide
Atorvastatin impurity E ent-atorvastatin
Atracurium besilate
Atracurium for impurity F identification
Atracurium for peak identification
Atropine
Atropine for peak identification
Atropine impurity B (1R,3r,5S)-8-azabicyclo[3.2.1]oct-3-yl (2RS)-3-hydroxy-2-phenylpropanoate (noratropine)
Atropine sulphate
Azaperone
Azathioprine
Azathioprine impurity A 1-methyl-4-nitro-1H-imidazol-5-amine
Azathioprine impurity G 6-[(1-methyl-4-nitro-1H-imidazol-5-yl)sulfanyl]-7H-purin-2-amine (thiamiprine)
Azelastine hydrochloride
Azelastine impurity B 1-benzoyl-2-[(4RS)-1-methylhexahydro-1H-azepin-4-yl]diazane
Azelastine impurity D 4-(4-chlorobenzyl)phthalazin-1(2H)-one
Azelastine impurity E 3-(4-chlorobenzilidene)isobenzofuran-1(3H)-one
50 mg
140 mg
1 mg
1 mg
100 mg
15 mg
10 mg
EPA1300000
EPY0001024
EPY0001170
EPY0000800
EPY0000305
EPA1320000
EPA1321000
EPA1330000
EPY0001171
EPA1340000
EPY0001089
EPY0001327
EPY0001328
EPY0001329
EPY0001330
EPY0001331
EPY0001332
EPY0000424
EPY0000503
EPY0000504
EPY0000878
EPY0000845
EPY0000816
EPA1400000
EPY0000029
EPA1500000
EPY0001240
EPY0001246
EPY0000326
EPY0000327
EPY0000328
EPY0000329
100 mg
20 mg
10 mg
10 mg
60 mg
40 mg
10 mg
50 mg
40 mg
100 mg
5 mg
150 mg
10 mg
10 mg
10 mg
10 mg
10 mg
120 mg
5 mg
5 mg
30 mg
0.25 mg
10 mg
50 mg
50 mg
100 mg
10 mg
5 mg
25 mg
5 mg
5 mg
5 mg
254 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. Edition 2012/2013
Table of content
European Pharmacopoeia
Code Product Unit
EPY0000306
EPY0000637
EPY0000641
EPY0000307
EPY0000285
EPB0070000
EPB0100000
EPB0200000
EPB0200050
EPY0001273
EPB0250000
EPB0300000
EPY0000295
EPB0305000
EPY0000351
EPY0000352
EPY0000469
EPY0001073
EPY0001025
EPY0001038
EPY0001026
Azithromycin
Azithromycin for peak identification
Azithromycin for system suitability
Azithromycin impurity A 6-demethylazithromycin
B19 virus DNA for NAT testing BRP
Bacampicillin hydrochloride
Bacitracin zinc
Baclofen
Baclofen impurity A (RS)-4-amino-3-(4-chlorophenyl)butyric acid lactam
Chlordiazepoxide impurity A 7-chloro-5-phenyl-1,3-dihydro-2H-1,4-benzodiazepin-2-one 4-oxide
Chlorhexidine
Chlorhexidine diacetate
Chlorhexidine dihydrochloride
Chlorhexidine for performance test
Chlorogenic acid
1-(4-Chlorophenyl)-1-phenylethanol Clemastine fumarate impurity C
Chloroquine sulphate
Chlorothiazide
Chlorphenamine maleate
Chlorphenamine impurity A 2-(4-chlorophenyl)-4-(dimethylamino)-2-[2-(dimethylamino)ethyl]butanenitrile
Chlorphenamine impurity C (3RS)-3-(4-chlorophenyl)-N-methyl-3-(pyridin-2-yl)propan-1-amine
Chlorpromazine hydrochloride
Chlorpromazine impurity A 3-(2-chloro-10H-phenothiazin-10-yl)-N,N-dimethylpropan-1- amine S-oxide (chlorpromazine sulphoxide)
Chlorpromazine impurity D 3-(2-chloro-10H-phenothiazin-10-yl)-N-methypropan-1-amine (demethylchlorpromazine)
Chlorpromazine impurity E 2-chloro-10H-phenothiazine
Chlorpromazine impurity F 3-(4-chloro-10H-phenothiazin-10-yl)-N,N-dimethylpropan-1-amine
Chlorpropamide
Chlorpropamide impurity B 1,3-Dipropylurea
unit
10 mg
15 mg
100 mg
1.01 mg
10 mg
unit
250 mg
60 mg
50 mg
20 mg
125 mg
30 mg
100 mg
10 mg
10 mg
500 mg
100 mg
25 mg
100 mg
1500 mg
100 mg
2x50 mg
100 mg
10 mg
50 mg
10 mg
50 mg
50 mg
20 mg
15 mg
200 mg
100 mg
100 mg
0.01 mg
10 mg
200 mg
10 mg
EPY0000479
New EPY0000508
EPY0001449
EPC1905000
EPC1905020
10 mg
10 mg
2 mg
100 mg
50 mg
260 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. Edition 2012/2013
Table of content
European Pharmacopoeia
Code Product Unit
EPC1915000
EPC1950000
EPY0000779
EPC2000000
EPY0001451
EPC2100000
EPC2150000
EPC2155000
EPC2158000
EPY0000280
EPY0000593
EPC2160000
EPY0000040
EPC2162701
EPC2162702
EPC2162700
EPC2163000
EPY0000361
EPC2170000
EPC2174000
EPC2174002
Chlorprothixene hydrochloride
Chlortalidone
Chlortalidone for peak identification
Chlortetracycline hydrochloride
Chlortetracycline for system suitability
Cholecalciferol
Cholecalciferol for system suitability
Cholesterol
Cholic acid
Chondroitin sulfate sodium
Chondroitin sulfate sodium (marine)
Chymotrypsin BRP
Ciclopirox
Ciclopirox impurity A (RS)-2-(3-cyclohexyl-5-methyl-4,5-dihydroisoxazol-5-yl)acetic acid
Ciclopirox impurity B 6-cyclohexyl-4-methyl-2H-pyran-2-one
Ciclopirox olamine
Ciclosporin
Ciclosporin for system suitability
Cilastatin sodium
Cilazapril
Cilazapril impurity A 1,1-dimethylethyl(1S,9S)-9-[[(S)-1-ethoxycarbonyl-3-phenylpropyl]amino]- 10-oxo-octahydro-6H-pyridazino[1,2a][1,2]diazepine-1-caboxylate
Cilazapril impurity D (1S,9S)-9-[[(R)-1-ethoxycarbonyl-3-phenylpropyl]amino]-10-oxo-octahydro-6H- pyridazino[1,2a][1,2]diazepine-1-carboxylic acid
Cimetidine
Cimetidine hydrochloride
Cimetidine for peak identification
Cimetidine for system suitability
Cinchocaine hydrochloride
Cineole
Cinnarizine
Ciprofibrate
Ciprofibrate for system suitability
Ciprofloxacin
Ciprofloxacin hydrochloride
Ciprofloxacin hydrochloride for peak identification
Ciprofloxacin impurity A 7-chloro-1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-quinoline-3-carboxylic acid (fluoroquinolonic acid)
Cisplatin
Cisplatin impurity A trans-diamminedichloroplatinium (II)
Cisplatin impurity B amminetrichloroplatinate (-)
Citalopram hydrobromide
Citalopram hydrochloride
Citalopram for system suitability
Citric acid (anhydrous)
Citric acid monohydrate
Cladribine
Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.
50 mg
150 mg
1.017 mg
100 mg
20 mg
500 mg
1 mL
100 mg
60 mg
250 mg
100 mg
100 mg
100 mg
20 mg
20 mg
150 mg
120 mg
5 mg
10 mg
50 mg
25 mg
EPC2174005 10 mg
EPC2175000
EPC2175500
EPY0001130
EPY0001146
EPC2177000
EPY0000176
EPC2180000
EPY0000362
EPY0000363
EPY0000198
EPC2190000
EPY0000199
EPC2190050
50 mg
100 mg
10 mg
0.5085 mg
60 mg
180 mg
100 mg
5 mg
5 mg
20 mg
100 mg
10 mg
10 mg
EPC2210000
EPY0001018
EPY0001019
EPY0001008
EPY0001007
EPY0000855
EPA1202000
EPC2219000
EPY0000639
Edition 2012/2013
100 mg
10 mg
10 mg
5 mg
5 mg
0.06 mg
50 mg
50 mg
50 mg
261
Table of content
European Pharmacopoeia
Code Product Unit
EPY0000609
EPY0000610
EPY0000320
EPY0000321
New EPY0001193
EPY0000269
EPC2221000
EPC2223000
EPC2248000
EPC2248010
EPC2250000
EPC2269000
EPY0000364
EPY0000205
EPY0000241
EPY0000559
EPY0000570
EPY0000571
Cladribine for peak identification
Cladribine impurity C 2-chloro-7H-purin-6-amine
Clarithromycin
Clarithromycin for peak identification
Clazuril
Clazuril for system suitability
Clebopride malate
Clemastine fumarate
Clenbuterol hydrochloride
Clenbuterol impurity B 1-(4-amino-3,5-dichlorophenyl)-2-[(1,1-dimethylethyl)amino]ethanone (clenbuterol ketone)
Clindamycin hydrochloride
Clindamycin phosphate
Clioquinol
Clobazam - Reference Spectrum
Clobazam impurity A 7-chloro-5-phenyl-1,5-dihydro-1,5-dihydro-3H-1,5-benzodiazepine-2,4-dione
268 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. Edition 2012/2013
Table of content
European Pharmacopoeia
Code Product Unit
EPY0000712
New EPY0001325
EPE0900000
EPE1000000
EPE1100000
EPE1200000
EPY0000051
EPY0000177
EPE1300000
EPE1305000
EPE1310000
EPE1320000
EPE1400000
EPE1500000
EPE1500800
EPE1515000
EPY0000324
EPY0000338
EPY0001028
EPY0000749
EPE1600000
EPY0000852
EPY0000045
EPE1620000
EPY0000314
EPY0000046
EPE1680000
EPE1680005
EPE1700000
EPE1800000
EPY0001263
EPE1830000
EPE1840000
EPE1850000
EPY0000803
EPA1202800
EPE1860100
EPE1900000
EPY0001124
EPE2000000
EPE2150000
EPE2250000
EPE2195000
EPE2195900
EPE2202000
EPE2205500
EPY0000617
EPE2300000
EPE2400000
Edition 2012/2013
Eq Influenza Subtype 2 American-like/South Africa Horse Antiserum BRP
Equisetum palustre
Ergocalciferol
Ergometrine maleate Drug Precursor
Ergosterol
Ergotamine tartrate Drug Precursor
Erysipelas ELISA coating antigen BRP
Erythritol
Erythromycin for microbiological assay
Erythromycin A
Erythromycin B
Erythromycin C
Erythromycin estolate
Erythromycin ethylsuccinate
Erythromycin stearate
Erythropoietin BRP
Esketamine hydrochloride - Reference Spectrum
Esketamine impurity D (2R)-2-(2-chlorophenyl)-2-(methylamino)cyclohexanone ((R)-ketamine)
Esomeprazole magnesium trihydrate
Essential oil
Estradiol benzoate
Estradiol benzoate for system suitability
Estradiol butyrate
Estradiol hemihydrate
Estradiol for peak identification
Estradiol valerate
Estriol
Estriol impurity A 9,11-didehydroestriol
Estrone
Etacrynic acid
Etacrynic acid for system suitability
Etamsylate
Ethacridine lactate monohydrate
Ethambutol hydrochloride
Ethambutol for system suitability
Ethanol (anhydrous) - Reference Spectrum
Ethanol 96% - Reference Spectrum
Ethinylestradiol
Ethinylestradiol for system suitability
Ethionamide
Ethosuximide
Ethosuximide impurity A (2RS)-2-ethyl-2-methylbutanedioic acid
Ethyl acetate - Reference Spectrum
Ethylcellulose - Reference Spectrum
1-N-Ethylgaramin sulfate
1,1'-Ethylidenebistryptophan
Ethyl indole-3-carboxylate
Ethylmorphine hydrochloride - Reference Spectrum
Ethylnicotinamide
Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.
3x1 mg
200 mg
500 mg
50 mg
20 mg
100 mg
0.4 mg
1000 mg
250 mg
250 mg
50 mg
50 mg
100 mg
10 mg
50 mg
37.5 mg
unit
10 mg
10 mg
1000 mg
250 mg
10 mg
10 mg
100 mg
10 mg
50 mg
50 mg
20 mg
15 mg
100 mg
10 mg
30 mg
50 mg
250 mg
10 mg
unit
unit
200 mg
25.31 mg
100 mg
30 mg
30 mg
unit
unit
50 mg
2x0.00167 mg
10 mg
unit
150 mg
269
Table of content
European Pharmacopoeia
Code Product Unit
EPE2425000
EPE2450000
EPE2451000
EPE2451010
EPY0000572
EPE2470000
EPE2470050
EPY0000768
EPE2499900
EPE2499901
EPE2499914
EPE2500000
EPE2503000
EPE2503004
EPE2600000
EPY0001365
EPE5000000
EPF0005000
EPY0000382
EPY0000409
EPY0000556
EPY0000660
EPY0000731
EPY0000732
EPF0030000
EPY0000415
EPF0040000
EPF0040010
EPF0040020
EPF0041000
EPF0048000
EPF0048005
EPF0048010
EPF0048035
Ethyl parahydroxybenzoate
Etifenin
Etilefrine hydrochloride
Etilefrine impurity A 2-ethylamino-1-(3-hydroxyphenyl)ethanone
Etidronate disodium
Etodolac
Etodolac impurity H 2-(7-ethylindol-3-yl)ethanol
Etodolac for peak identification
Etofenamate
Etofenamate for peak identification
Etofenamate impurity G 2-hydroxyethyl 2-[[3-(trifluoromethyl)phenyl]amino]-benzoate
Etofylline
Etomidate
Etomidate impurity B methyl 1-[(1RS)-1-phenylethyl]-1H-imidazole-5-carboxylate
Etoposide
Etoposide for system suitability
Eugenol
Famotidine
Famotidine for system suitability
Famotidine impurity D 3-[[[2-[(diaminomethylene)amino]thiazol-4-yl]methyl]sulphanyl]propanamide
Febantel
Febantel for system suitability
Felbinac
Felbinac impurity A 4-acetyl biphenyl
Felodipine
Felypressin
Fenbendazole
Fenbendazole impurity A methyl(1H-benzimidazol-2-yl)carbamate
Fenbendazole impurity B methyl[5(6)-chlorobenzimidazol-2-yl]carbamate
Fenbufen
Fenofibrate
Fenofibrate impurity A (4-chlorophenyl)(4-hydroxyphenyl)methanone
Fenofibrate impurity B 2[4-(4-chlorobenzoyl)phenoxy]-2-methylpropanoic acid (fenofibric acid)
Fenofibrate impurity G 1-methylethyl 2-[[2-[4-(4-chlorobenzoyl)phenoxy]-2-methylpropanoyl] oxy]-2-methylpropanoate
Fenoterol for peak identification
Fenoterol hydrobromide
Fentanyl - Reference Spectrum
Fentanyl for system suitability Controlled Substance
Fentanyl citrate - Reference Spectrum
Fenticonazole nitrate
Fenticonazole impurity D (RS)-1-[2-(2,4-dichlorophenyl)-2-hydroxyethyl]-3- [4-(phenyl suphanyl)benzyl]imidazolium nitrate
150 mg
25 mg
75 mg
20 mg
10 mg
60 mg
10 mg
10 mg
40 mg
15 mg
20 mg
100 mg
50 mg
25 mg
150 mg
10 mg
500 µL
100 mg
10 mg
10 mg
110 mg
10 mg
10 mg
20 mg
120 mg
0.994 mg
150 mg
20 mg
20 mg
100 mg
100 mg
20 mg
10 mg
25 mg
EPY0000756
EPF0050000
EPF0054990
New EPY0001509
EPF0055000
EPF0060000
EPF0060040
1.2 mg
100 mg
unit
25 mg
unit
50 mg
20 mg
270 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. Edition 2012/2013
Table of content
European Pharmacopoeia
Code Product Unit
EPF0100000
EPY0001013
EPY0000789
EPY0000751
Ferrous gluconate
Ferulic acid
Fexofenadine hydrochloride
Fexofenadine impurity A 2-[4-[4-[4-(hydroxydiphenylmethyl)piperidin-1-yl] butanoyl]phenyl]-2-methylpropanoic acid
Fexofenadine impurity B 2-[3-[(1RS)-1-hydroxy-4-[4-(hydroxydiphenylmethyl)piperidin-1-yl]butyl]phenyl]-2- methylpropanoic acid
Fexofenadine impurity C (1RS)-4-[4-(hydroxydiphenylmethyl)piperidin-1-yl]-1-[4-(1-methylethyl)phenyl]butan-1-ol
Filgrastim
Finasteride
Finasteride for system suitability
Flavoxate hydrochloride
Flavoxate impurity A 3-methyl-4-oxo-2-phenyl-4H-1-benzopyran-8-carboxylic acid
Flavoxate impurity B ethyl 3-methyl-4-oxo-2-phenyl-4H-1-benzopyran-8-carboxylate
Flecainide acetate
Flecainide impurity A 3-[2,5-bis(2,2,2-trifluoroethoxy)phenyl]-1,5,6,7,8,8a- hexahydroimidazo[1,5-a]pyridine
Flecainide impurity B (RS)-(piperidin-2-yl)methanamine
Flecainide for system suitability
Flubendazole
Flubendazole for system suitability
Flucloxacillin magnesium octahydrate
Flucloxacillin impurity C 6-aminopenicillanic acid
Flucloxacillin impurity D 3-(2-chloro-6-fluorophenyl)-5-methylisoxazole-4-carboxylic acid
Flucloxacillin impurity E 6-aminopenicillanic acid flucloxacillin amide
Flucloxacillin sodium
Fluconazole
Fluconazole for peak identification
Fluconazole impurity B 2-[2-fluro-4-(1H-1,2,4-triazol-1-yl)phenyl]-1,3-bis(1H-1,2,4-triazol-1-yl)propan-2-ol
Fluconazole impurity C 1,1´-(1,3-phenylene)di-1H-1,2,4-triazole
Flucytosine
Flucytosine for system suitability
Fludarabine phosphate
Fludrocortisone acetate
Flumazenil - Reference Spectrum
Flumazenil impurity B ethyl 8-hydroxy-5-methyl-6-oxo-5,6-dihydro-4H-imidazo [1,5-a][1,4]benzodiazepine-3-carboxylate
Flumequine
Flumequine impurity B ethyl(RS)-9-fluoro-5-methyl-1-oxo-6,7-dihydro-1H,5H-benzo[i,j] quinolizine-2-carboxylate
Flumetasone pivalate
Flunarizine dihydrochloride
Flunarizine dihydrochloride - Reference Spectrum
Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.
100 mg
20 mg
60 mg
5 mg
EPY0000752 0.01 mg
EPY0000753
EPY0001173
EPY0000090
EPY0000091
EPY0000736
EPY0000737
EPY0000738
EPF0120000
EPF0120005
5 mg
0.2 mL
60 mg
100 mg
10 mg
10 mg
10 mg
200 mg
50 mg
EPF0120010
EPY0001274
EPY0000138
EPY0000139
EPY0000892
EPY0000889
EPY0000890
EPY0000891
EPF0150000
EPY0000557
EPY0000558
EPY0000573
EPY0000574
EPF0175000
EPY0001262
EPY0000419
EPF0180000
EPF0188000
EPY0000335
25 mg
10 mg
25 mg
20 mg
5 mg
5 mg
5 mg
5 mg
250 mg
50 mg
10 mg
10 mg
5 mg
100 mg
10 mg
120 mg
100 mg
unit
5 mg
EPF0189000
EPF0189020
60 mg
0.1 mg
EPF0188500
EPF0189900
EPY0000265
Edition 2012/2013
100 mg
100 mg
unit
271
Table of content
European Pharmacopoeia
Code Product Unit
EPY0000266
EPF0190000
EPY0000169
EPY0000443
EPY0000444
EPY0000445
EPF0200000
EPF0230000
EPY0000796
EPY0000804
EPY0000454
EPF0245000
EPF0250000
EPY0000762
EPY0000763
EPY0000764
EPY0000765
EPY0000791
EPF0253000
EPF0253020
EPF0253030
EPY0000064
EPY0000067
Flunarizine dihydrochloride for system suitability
Flunitrazepam Controlled Substance
Flunitrazepam - Reference Spectrum
Flunixin meglumine
Flunixin impurity B 2-methyl-3-(trifluoromethyl)aniline
Flunixin impurity C ethyl 2-chloropyridine-3-carboxylate
Fluocinolone acetonide
Fluocortolone pivalate
Fluorescein
Fluorescein impurity C 2-(2,4-dihydroxybenzoyl)benzoic acid
Diacetylfluorescein
Fluoresceine sodium - Reference Spectrum
Fluorouracil
Fluorouracil impurity A pyrimidine-2,4,6(1H,3H,5H)-trione (barbituric acid)
Fluorouracil impurity B dihydropyrimidine-2,4,5(3H)-trione (isobarbituric acid or 5-hydroxyuracil)
Fluorouracil impurity C pyrimidine-2,4(1H,3H)-dione (uracil)
Fluorouracil impurity F 2-ethoxy-5-fluoropyrimidin-4(1H)-one (2-ethoxy-5-fluorouracil)
Fluorouracil impurity mixture
Fluoxetine hydrochloride
Fluoxetine impurity B methyl(3-phenylpropyl)amine Controlled Substance
Fluoxetine impurity C (RS)-methyl-[3-phenyl-3-(3-trifluoromethylphenoxy)-propyl]amine
Flupentixol dihydrochloride
Flupentixol impurity D 2-[2-[4-[3-[(EZ)-2-(trifluoromethyl)-9H-thioxanthen-9-ylidene]propyl] piperazin-1-yl]ethoxy]ethanol
Flupentixol impurity F 2-[4-[(EZ)-3-[(9RS)-2-(trifluoromethyl)-9H-thioxanthen-9-yl)prop-2-enyl]- piperazin-1-yl]ethanol
Fluphenazine decanoate
Fluphenazine enantate
Fluphenazine dihydrochloride
Fluphenazine impurity mixture
Fluphenazine octanoate
Fluphenazine sulphoxide
Flurazepam monohydrochloride - Reference Spectrum
Flurbiprofen
Flurbiprofen impurity A (2RS)-2-(biphenyl-4-yl)propanoic acid
Fluspirilene
Fluspirilene impurity C 8-[4,4-bis((4-fluorophenyl)butyl]-3-(hydroxymethyl)-1- phenyl-1,3,8-triazaspiro[4.5]decan-4-one
Flutamide
Flutamide impurity C N-[4-nitro-3-(trifluoromethyl)phenyl]propanamide
Fluticasone propionate
20 mg
100 mg
unit
10 mg
10 mg
50 mg
100 mg
100 mg
120 mg
0.01 mg
100 mg
unit
40 mg
10 mg
10 mg
10 mg
10 mg
0.0002 mg
250 mg
10 mg
5 mg
100 mg
15 mg
EPY0000078 25 mg
EPF0260000
EPY0000009
EPF0280000
EPY0000708
EPY0000298
EPY0000299
EPY0000211
EPF0285200
EPF0285202
EPY0000236
EPY0000375
60 mg
100 mg
50 mg
0.07 mg
20 mg
10 mg
unit
50 mg
20 mg
20 mg
10 mg
EPF0285600
EPF0285603
EPY0000284
50 mg
20 mg
100 mg
272 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. Edition 2012/2013
Table of content
European Pharmacopoeia
Code Product Unit
EPY0000221 Fluticasone impurity D S-methyl 6a,9a-difluoro-11b-hydroxy-16a-methyl-3-oxo-17a-propionyloxy-androsta- 1,4-diene-17β-carbothioate (S-methyl derivative)
Flutrimazole
Flutrimazole impurity B (RS)-(2-fluorophenyl)(4-fluorophenyl)phenylmethanol
Fluvastatin sodium
Fluvastatin for system suitability
Fluvoxamine maleate
Fluvoxamine for system suitability
Fluvoxamine impurity D 5-methoxy-1-[4-(trifluoromethyl)phenyl]pentan-1-one
Foeniculin for peak identification Anise oil
Folic acid
Folic acid impurity A (2S)-2-[(4-aminobenzoyl)amino]pentanedioic acid (N-(4-aminobenzoyl)-l-glutamic acid)
Folic acid impurity D 4-[[(2-amino-4-oxo-1,4-dihydropteridin-6-yl)methyl]amino]benzoic acid (pteroic acid)
Formoterol fumarate dihydrate
Formoterol for impurity I identification
Formoterol fumarate for system suitability
Formylfolic acid 10-Formylfolic acid
Foscarnet sodium hexahydrate
Foscarnet impurity B disodium(ethoxyoxydophosphanyl)formate
Foscarnet impurity D Ethyl (diethoxyphosphinyl)formate
Foscarnet impurity mixture
Fosfomycin calcium
Fosfomycin sodium - Reference Spectrum
Fosfomycin trometamol
Fosinopril sodium
Fosinopril impurity A (2S,4S)-4-cyclohexyl-1-[[(R)-hydroxy(4-phenylbutyl)phosphoryl] acetyl]pyrrolidine-2-carboxylic acid
Fosinopril impurity B (2RS,4RS)-4-cyclohexyl-1-[[(RS)-[(1SR)-2-methyl-1-(1-oxopropoxy)propoxy](4- phenylbutyl)phosphoryl]acetyl]pyrrolidine-2-carboxylic acid
Fosinopril impurity C mixture of (2S,4S)-4-cyclohexyl-1-[[(S)-[(1S)-2-methyl-1-(1-oxopropoxy)propoxy](4- phenylbutyl)phosphoryl]acetyl]pyrrolidine-2-carboxylic acid and (2S,4S)-4-cyclohexyl-1-[[(R)- [(1R)-2-methyl-1-(1-oxopropoxy)propoxy](4-phenylbutyl)phosphoryl]acetyl]pyrrolidine-2- carboxylic acid
Fosinopril impurity D (2S,4R)-4-cyclohexyl-1-[[(R)-[(1S)-2-methyl- 1-(1-oxopropoxy)propoxy](4-phenylbutyl) phosphoryl]acetyl]pyrrolidine-2-carboxylic acid
Fosinopril impurity I [(RS)-[(1SR)-2-methyl-1-(1-oxopropoxy)propoxy](4-phenylbutyl) phosphoryl]acetic acid
Fosinopril impurity K (2S,4S)-4-cyclohexyl-1-(2,2-dimethyl-1-oxopropyl) pyrrolidine-2-carboxylic acid
Fosinopril impurity mixture
Framycetin sulphate
Fructose
20 mg
EPF0290000
EPF0290010
EPY0001090
EPY0001082
EPY0000854
EPY0000853
EPY0000916
EPY0000386
EPF0300000
EPY0001242
100 mg
60 mg
110 mg
0.5 mg
5 mg
1.004 mg
10 mg
100 mg
2x150mg
15 mg
EPY0001243
EPF0372000
EPY0000339
EPY0000340
EPF0380000
EPF0389000
EPF0389004
EPY0001222
EPY0001213
EPY0000782
EPF0399950
EPF0400000
EPY0001227
EPY0001228
70 mg
10 mg
10 mg
10 mg
30 mg
50 mg
10 mg
50 mg
0.012 mg
10 mg
unit
1500 mg
60 mg
5 mg
EPY0001229 5 mg
EPY0001230 10 mg
EPY0001231 10 mg
EPY0001232 5 mg
EPY0001233 5 mg
EPY0001212
EPF0450000
EPF0550000
0.02 mg
2x25 mg
100 mg
Edition 2012/2013 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. 273
Table of content
European Pharmacopoeia
Code Product Unit
New EPY0001399
New EPY0001413
EPF0600000
EPF0700000
New EPY0001493
EPF0702000
New EPY0001411
EPF1000000
New EPY0001394
New EPY0001384
EPY0001280
EPY0001281
EPY0001348
EPY0001349
EPG0049000
EPG0050000
EPY0001279
EPY0001190
EPY0001201
EPY0001191
EPG0100000
EPG0150000
EPY0001129
EPY0001144
EPY0000675
EPY0000676
EPY0000513
EPY0000514
EPG0200000
EPY0001363
EPY0001112
EPY0001110
EPY0001116
EPY0001012
EPY0001010
EPG0300000
EPG0325000
New EPY0001511
EPG0325010
EPY0000242
EPG0326000
EPG0326004
EPG0326012
EPY0000515
Fulvestrant
Fulvestrant for system sitability
Fumaric acid
Furosemide
Furosemide for peak identification
Furosemide impurity A 2-chloro-4-(furfurylamino)-5-sulphamoylbenzoic acid
Fusidic acid
Fusidic acid - Reference Spectrum
Fusidic acid for peak identification
Fusidic acid impurity mixture
Gabapentin
Gabapentin impurity A 2-azaspiro[4.5]decan-3-one
Gabapentin impurity B (1-cyanocyclohexyl)acetic acid
Gabapentin impurity D [1-[(3-oxo-2-azaspiro[4.5]dec-2-yl)methyl]cyclohexyl]acetic acid
Galactitol
Galactose
Galantamine hydrobromide
Galantamine natural for system suitability
Galantamine racemic mixture
Galantamine synthetic for system suitability
Gallamine triethiodide
Gammacyclodextrin
Ganciclovir
Ganciclovir impurity mixture
Gemcitabine hydrochloride
Gemcitabine impurity A 4-aminopyrimidin-2(1H)-one (Cytosine)
Gemfibrozil
Gemfibrozil for system suitability
Gentamicin sulphate
Gentamicin for peak identification
Gestodene
Gestodene for system suitability
Gestodene impurity I 13-ethyl-17-hydroxy-5-methoxy-18,19-dinor-5alpha,17alpha-pregn-15-en-20-yn-3-one
Ginkgo dry extract for peak identification
Ginkgolic Acid
Gitoxin
Glibenclamide
Glibenclamide for peak identification
Glibenclamide impurity A 4-[2-(5-Chloro-2-methoxybenzamido)ethyl]benzenesulphonamide
Glibenclamide impurity B methyl [[4-[2-[(5-chloro-2-methoxybenzoyl)amino]ethyl]phenyl] sulphonyl]carbamate
Gliclazide
Gliclazide impurity B 2-nitroso-octahydrocyclopenta[c]pyrrole
Gliclazide impurity F 1-(hexahydrocyclopenta[c]pyrrol-2-(1H)-yl-3-[(2-methylphenyl)sulphonyl]urea
Glimepiride
120 mg
40 mg
120 mg
100 mg
10 mg
5 mg
10 mg
unit
5 mg
0.0475 mg
300 mg
20 mg
20 mg
10 mg
50 mg
60 mg
10 mg
10 mg
10 mg
5 mg
100 mg
50 mg
220 mg
0.005 mg
50 mg
20 mg
5 mg
0.196 mg
2x25 mg
10 mg
100 mg
10 mg
0.01 mg
150 mg
20 mg
30 mg
100 mg
30 mg
10 mg
20 mg
20 mg
25 mg
50 mg
60 mg
274 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. Edition 2012/2013
Table of content
European Pharmacopoeia
Code Product Unit
EPY0000516
EPG0340000
EPG0342000
EPY0000523
EPY0000643
EPY0001140
EPY0000191
New EPY0001406
New EPY0001381
New EPY0001407
EPG0350500
EPG0355000
EPY0000517
EPG0360000
EPG0400000
EPG0400004
New EPY0001391
EPY0000794
EPY0000795
EPG0400006
EPG0400007
EPG0400008
EPG0400101
EPG0400100
EPG0450000
EPY0001308
EPY0001309
EPY0001358
EPY0000433
EPG0460000
EPG0525000
EPY0000125
EPY0000126
New EPY0001473
EPY0000019
EPY0000194
EPG0550000
EPY0000396
EPY0000477
Glimepiride for system suitability
Glipizide
Glipizide impurity A 4-[2-(5-methylpyrazine-2-carboxamido)ethyl]benzene sulphonamide
Glipizide impurity C ethyl 2-[4-[(cyclohexylcarbamoyl)sulphamoyl]phenyl]ethyl]carbamate
Glipizide impurity D 6-methyl-N-[2-(4-sulphamoylphenyl)ethyl]pyrazine-2-carboxamide
Glipizide impurity mixture
Human glucagon
Glucosamine hydrochloride
Glucosamine for system suitability
Glucosamine sulfate sodium chloride
Glucose
Glutamic acid
Glutathione
Glutethimide Controlled Substance
Glycerol (85 per cent) - Reference Spectrum
Glycerol distearate
Glycerol formal
Glycerol monocaprylate
Glycerol monocaprylocaprate
Glycerol monolinoleate
Glycerol mono-oleate
Glycerol monostearate 40-55
Glyceryl trinitrate - Reference Spectrum
Glyceryl trinitrate solution
Glycine
Glycopyrronium bromide
Glycopyrronium for peak identification
Glycopyrronium impurity N (3RS)-3-[(2RS)-(2-cyclopentyl-2-hydroxy-2-phenylacetyl)oxy]-1,1-dimethylpyrrolidinium
Ammonium glycyrrhizate
Glycyrrhizate (monoammonium)
Gonadorelin
Goserelin
Gosereline - Reference Spectrum
Goserelin for NMR identification
4-D-Ser-goserelin
Goserelin validation mixture
Gramicidin
Granisetron hydrochloride
Granisetron impurity A 2-methyl-N-[(1R,3r,5S)-9-methyl-9-azabicyclo[3.3.1] non-3-yl]-2H-indazole-3-carboxamide
Granisetron impurity B N-[(1R,3r,5S)-9-methyl-9-azabicyclo[3.3.1]non-3-yl]-1H-indazole-3-carboxamide
Granisetron impurity E (1R,3r,5S)-9-methyl-9-azabicyclo[3.3.1]nonan-3-amine
Griseofulvin
Guaiacol
Guaifenesin
Halofantrine hydrochloride
0.012 mg
50 mg
10 mg
10 mg
10 mg
0.002 mg
2x2.94mg
10 mg
40 mg
15 mg
100 mg
50 mg
10 mg
50 mg
unit
2000 mg
2x20 mg
400 mg
500 mg
2000 mg
2000 mg
2000 mg
unit
0.5 mL
50 mg
10 mg
10 mg
10 mg
70 mg
300 mg
5 mg
2 mg
unit
14 mg
0.1 mg
1 mg
250 mg
120 mg
1 mg
EPY0000478
EPY0000395
EPG0600000
EPY0000619
EPG0700000
EPY0000117
1 mg
2x15 mg
50 mg
2200 mg
100 mg
125 mg
Edition 2012/2013 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. 275
Table of content
European Pharmacopoeia
Code Product Unit
EPY0000118
EPH0100000
New EPY0001517
New EPY0001518
EPH0100100
EPH0150000
EPY0000673
EPY0001287
EPY0001282
EPH0185000
EPH0190000
EPH0200000
EPY0001283
EPH0205010
EPY0001192
EPY0000389
EPH0210010
EPH0215000
EPH0220000
EPY0000063
EPY0000057
EPH0250000
EPH0330000
EPH0325000
EPH0400000
EPH0420000
EPH0500000
EPH0600000
EPH0700000
EPH0750000
EPH0755000
EPH0800000
EPH0830000
New EPY0001383
EPH0837000
EPH0900000
EPY0000219
EPY0000667
EPH0920000
EPH0920500
EPH0950000
EPH0990000
EPH1000000
EPY0000488
EPH1005000
EPH1100000
EPH1110000
EPY0000502
EPH1115000
Halofantrine impurity C [1,3-dichloro-6-(trifluoromethyl)phenantren-9-yl]methanol
Haloperidol
Haloperidol for system suitability
Haloperidol for peak identification
Haloperidol decanoate
Halothane - Reference Spectrum
Harpagoside
Heparin calcium for NMR identification
Heparin for Physio-Chemical Analysis
Heparin Low-Molecular-Mass for assay BRP
Heparin Low-Molecular-Mass for calibration CRS
Heparin sodium BRP
Heparin sodium for NMR identification
Hepatitis A vaccine (inactivated,absorbed) Type B BRP
Hepatitis A Vaccine (Inactivated, Non-Adsorbed)
Hepatitis B vaccine (rDNA) BRP method A (thiomersal free)
Hepatitis B vaccine (rDNA) BRP method B
Hepatitis C Virus RNA for NAT testing BRP
Heptadecanol
Heptaminol hydrochloride
Heptaminol impurity A (2RS)-6-methylhept-5-en-2-amine
Hydrocodone for peak identification Controlled Substance
Hydrocortisone
Hydrocortisone for peak identification
Hydrocortisone acetate
Hydrocortisone acetate for peak identification
Hydrocortisone hydrogen succinate
Hydrogenated wool fat
Hydromorphone hydrochloride Controlled Substance
Hydrous benzoyl peroxide - Reference Spectrum
Hydroxocobalamin
Hydroxycarbamide
Hydroxyethyl salicylate
Hydroxyethyl starch (high Mw)
Hydroxyethyl starch (medium MW)
4-Hydroxyphenoxymethylpenicillin potassium
D-alpha-(4-Hydroxy-phenyl)glycine (2R)-2-amino-2-(4-hydroxyphenyl)acetic acid - Cefadroxyl impurity A
Hydroxypropylbetadex
Hydroxyzine hydrochloride
Hymecromone
Hymecromone impurity A Resorcinol
Hymecromone impurity B 7-hydroxy-2-methyl-4H-1-benzopyran-4-one
Hyoscine
Hyoscine impurity A (1R,2R,4S,5S,7s)-3-oxa-9-azatricyclo[3.3.1.02,4]non-7-yl (2S)-3-hydroxy-2- phenylpropanoate (norhyoscine)
Hyoscine butylbromide
Hyoscine butylbromide impurity E (1R,2R,4S,5S,7S)-9-butyl-7-[[(2S)-3-hydroxy-2-phenylpropanoyl]oxy]-3-oxa- 9-azoni atricyclo[3.3.1.02,4]nonane
Hyoscine hydrobromide
Hyoscine hydrobromide impurity B (1R,2R,4S,5S,7s)-3-oxa-9-azatricyclo[3.3.1.02,4]non-7-yl(2S)- 3-hydroxy-2-phenylpropanoate
Hyoscyamine sulfate
Hyoscyamine impurity E (1R,3s,5S)-8-azabicyclo[3.2.1] oct-3-yl(2S)-3-hydroxy-2-phenylpropanoate
Hypromellose phthalate
Ibuprofen
Ibuprofen impurity B (2RS)-2-(4-Butylphenyl)propionic acid (0,06% solution in Acetonitrile)
Ibuprofen impurity F 3-[4-(2-methylpropyl)phenyl]propanoic acid
Ibuprofen for peak identification
Idoxuridine
Ifosfamide
Ifosfamide - Reference Spectrum
20 mg
20 mg
160 mg
10 mg
10 mg
10 mg
100 mg
5 mg
125 mg
15 mg
100 mg
250 mg
10 mg
unit
10 mg
175 mg
125 mg
800 mg
1200 mg
20 mg
50 mg
10 mg
600 mg
100 mg
25 mg
25 mg
10 mg
10 mg
EPH1450000
EPY0000447
20 mg
10 mg
EPH1500000
EPY0000448
50 mg
10 mg
EPH1600000
EPY0000449
EPY0000915
EPI0020000
EPB1220000
EPY0000140
EPY0000881
EPI0050000
EPI0060000
EPI0060100
100 mg
10 mg
10 mg
250 mg
1.15 mL
5 mg
0.09 mg
50 mg
50 mg
unit
Edition 2012/2013 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. 277
Table of content
European Pharmacopoeia
Code Product Unit
EPI0060002
EPI0060004
EPI0060010
EPI0060012
EPI0086000
EPI0090000
EPI0100000
EPY0000893
EPY0001153
EPY0000540
EPY0001205
EPI0150000
EPI0150020
EPY0000788
EPY0000880
EPY0000746
EPI0200000
EPY0000349
EPI0305000
EPI0310000
EPY0000348
EPI0320000
EPI0320300
EPI0320301
EPY0001101
EPI0320330
EPI0320331
EPI0328000
EPY0000839
EPY0001294
EPY0001292
Ifosfamide impurity A 3-[(2-chloroethyl)amino]propyl dihydrogen phosphate
Ifosfamide impurity B bis[3-[(2-chloroethyl)amino]propyl]dihydrogen diphosphate
Ifosfamide impurity E 3-chloro-N-(2-chloroethyl)propan-1-amine
Ifosfamide impurity F (RS)-2-chloro-3-(2-chloroethyl)-1,3,2-oxazaphosphinane 2-oxide
Imidazole
Imipenem
Imipramine hydrochloride
Imipramine for system suitability
Immunoglobulin for anti-A, anti-B antibodies limit test
Immunoglobulin panel for anti-D antibodies test BRP
Imperatorin
Indapamide
Indapamide impurity B 4-chloro-N-(2-methyl-1H-indol-1-yl)-3-sulphamoylbenzamide
Indinavir
Indinavir sulfate - Reference Spectrum
Indinavir for system suitability
Indometacin
Insulin aspart
Insulin (bovine)
Insulin (human)
Insulin lispro
Insulin (porcine)
Interferon alfa-2a
Interferon alfa-2b
Interferon beta-1a
Interferon gamma 1b
Interferon gamma-1b validation solution
Iobenguane sulfate
Iobenguane sulphate - Reference Spectrum
Iodixanol
Iodixanol impurity C 5-[acetyl[3-[[3,5-bis[(2,3-dihydroxypropyl)carbamoyl]-2,4,6-triiodophenyl]amino]-2- hydroxypropyl]amino]-N,N'-bis(2,3-dihydroxypropyl)-2,4,6-triiodobenzene-1,3-dicarboxamide
Iodixanol impurity E 5-[acetyl[3-[acetyl[3-carbamoyl-5-[(2,3-dihydroxypropyl)carbamoyl]-2,4,6- triiodophenyl]amino]-2-hydroxypropyl]amino]-N,N'-bis(2,3-dihydroxypropyl)-2,4,6- triiodobenzene-1,3-dicarboxamide
Iodixanol impurity H 5-[acetyl[3-[acetyl[3-[[3-[3-[acetyl[3,5-bis[(2,3-dihydroxypropyl)carbamoyl]-2,4,6- triiodophenyl]amino]-2-hydroxypropoxy]-2-hydroxypropyl]carbamoyl]-5-[(2,3- dihydroxypropyl)carbamoyl]-2,4,6-triiodophenyl]amino]-2-hydroxypropyl]amino]-N,N'-bis(2,3- dihydroxypropyl)-2,4,6-triiodobenzene-1,3-dicarboxamide
Iohexol
Iohexol impurity A 5-acetamido-N,N'-bis(2,3-dihydroxypropyl)-2,4,6-tri-iodobenzene-1,3- dicarboxamide
Plastic additive 14 2,2'-Di(octadecycloxy)5,5'-spirobi(1,3,2,-dioxaphosphorinane) R
Plastic additive 15 Dioctadecyl disulphide
Plastic additive 16 Didodecyl 3,3'-thiodipropionate R
Plastic additive 17 Dioctadecyl 3,3'-thiodipropionate R
Plastic additive 18
Plastic additive 20 Oleamide R
Plastic additive 21 Erucamide R
Plastic additive 22 Copolymer of dimethyl butanedioate and 1-(2-hydroxyethyl)-2,2,6,6-tetramethylpiperidin-4-ol Synonyms: copolymer of dimethyl succinate and (4-hydroxy-2,2,6,6-tetramethylpiperidin-1- yl)ethanol
Plastic additive 23 di(isooctyl)2,2'-[(dioctylstannylene)bis(thio)]diacetate containing about 27% of (tri(isooctyl)2,2',2''-[monooctylstannylidyne)tris(thio)]triacetate Tin-content of 15.4%
Poliomyelitis vaccine (inactivated) BRP
Poliomyelitis vaccine (oral) BRP
Poloxamer 124
Poloxamer 188
Poloxamer 237
Poloxamer 338
Poloxamer 407
Polyacrylate - Reference Spectrum
Polymyxin B sulfate
Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on.
100 mg
10 mg
20 mg
100 mg
50 mg
100 mg
10 mg
EPP2155001
EPP2155003
EPE0800000
EPP2155005
EPP2155008
EPP2155009
EPP2155010
EPP2155011
EPP2155012
EPP2155013
EPP2155014
EPP2155015
EPP2155016
EPP2155017
EPP2155018
EPO0140000
EPE1260000
EPP2155022
2 mL
100 mg
500 mg
500 mg
500 mg
250 mg
250 mg
500 mg
250 mg
250 mg
250 mg
500 mg
250 mg
250 mg
100 mg
100 mg
100 mg
100 mg
EPP2155023 200 mg
EPP2160000
EPP2161000
EPP2163920
EPP2164009
EPP2164020
EPP2164021
EPP2164030
EPP2170000
EPP2400000
294
5x0.5 mL
5x1 mL
30 mg
100 mg
100 mg
100 mg
100 mg
unit
25 mg
Edition 2012/2013
Table of content
European Pharmacopoeia
Code Product Unit
EPY0000355
EPY0000289
EPY0000290
EPY0000291
EPY0000007
EPY0000792
EPP2600000
EPP2649610
EPY0001168
EPY0000315
EPP2650000
EPY0001275
EPP2660000
EPY0000466
EPY0001266
EPY0001187
EPY0001267
EPY0000215
EPY0000223
Polymyxin B sulfate for microbiological assay
Polysorbate 20 - Reference Spectrum
Polysorbate 40 - Reference Spectrum
Polysorbate 60 - Reference Spectrum
Polysorbate 80 - Reference Spectrum
Poly(vinyl acetate) dispersion 30%
Poly(vinyl chloride)
Potassium clavulanate - Reference Spectrum
Potassium clavulanate impurity G
Potassium hydrogen aspartate hemihydrate
Potassium sorbate
Potassium sucrose octasulfate
Povidone
Povidone (iodinated)
Pramipexole dihydrochloride monohydrate
Pramipexole for system suitability
Pramipexole impurity D (6R)-6-N-propyl-4,5,6,7-tetrahydro-1,3-benzothiazole-2,6-diamine
Pravastatin sodium - Reference Spectrum
Pravastatin impurity A (3R,5R)-3,5-dihydroxy-7-[(1S,2S,6R,8S,8aR)-6-hydroxy-2-methyl-8-[[(2S)- 2-methylbutanoyl]oxy]-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]heptanoic acid (6'-epipravastatin)
Pravastatin 1,1,3,3-tetramethylbutylamine
Prazepam Controlled Substance
Praziquantel
Praziquantel impurity A (11bRS)-2-benzoyl-1,2,3,6,7,11b-hexahydro-4H-pyrazino[2,1-a]isoquinolin-4-one
Prazosin hydrochloride
Prednicarbate
Prednicarbate for system suitability
Prednicarbate impurity F 1,2-dihydroprednicarbate
Prednisolone
Prednisolone for peak identification
Prednisolone for system suitability
Prednisolone acetate
Prednisolone acetate for peak identification
Prednisolone hexanoate
Prednisolone pivalate
Prednisolone sodium phosphate
Prednisone
Pregnenolone isobutyrate
Prekallikrein activator in albumin BRP
Prilocaine
Prilocaine hydrochloride
Prilocaine impurity B 2-methylbenzenamine hydrochloride
Prilocaine impurity E (RS)-N-(methylphenyl)-2-(propylamino)propanamide
Primaquine diphosphate
Primidone
Primidone for peak identification
25 mg
unit
unit
unit
unit
1500 mg
100 mg
unit
5 mg
50 mg
100 mg
100 mg
50 mg
10 mg
5 mg
15 mg
5 mg
unit
0.1 mg
EPY0000204
EPP2669000
EPP2670000
EPP2675000
EPP2680000
EPP2698000
New EPY0001443
EPP2698060
EPP2700000
EPY0001359
EPY0001355
EPP2800000
EPY0000582
EPP2804000
EPP2805000
EPP2810000
EPP2900000
EPP2920000
EPY0000263
EPP2939000
EPP2939060
New EPY0001408
EPP2939025
EPP2940000
EPP2950000
EPY0000369
30 mg
50 mg
150 mg
10 mg
50 mg
100 mg
10 mg
10 mg
150 mg
10 mg
10 mg
120 mg
10 mg
10 mg
100 mg
100 mg
100 mg
150 mg
3x1 mL
150 mg
100 mg
80 mg
25 mg
500 mg
150 mg
5 mg
Edition 2012/2013 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. 295
Table of content
European Pharmacopoeia
Code Product Unit
EPP3000000
EPP3050000
EPP3090000
EPP3100000
EPP3200000
EPP3300000
EPY0000148
EPY0000179
EPY0000181
EPY0000182
EPP3350000
EPP3390000
EPP3400000
EPY0000769
EPY0000797
EPP3490000
EPY0000455
EPY0000456
Probenecid
Procainamide hydrochloride
Procaine benzylpenicillin
Procaine hydrochloride
Prochlorperazine maleate
Progesterone
Progesterone impurity C (20R)-20-hydroxypregn-4-en-3-one
Proguanil hydrochloride - Reference Spectrum
Proguanil impurity C 1,5-bis(4-chlorophenyl)biguanide
Proguanil impurity D 1,5-bis(1-methylethyl)biguanide
Proline
Promazine hydrochloride
Promethazine hydrochloride
Promethazine impurity D (2RS)-N,N-dimethyl-1-(10H-phenothiazin-10-yl)propan-2-amine S-oxide
Promethazine for peak identification
Propacetamol hydrochloride - Reference Spectrum
Propafenone hydrochloride
Propafenone impurity B 2E)-1-[2-[(2RS)-2-hydroxy-3-(propylamino)propoxy] phenyl]-3-phenylprop-2-en-1-one
Tinidazole impurity A 2-methyl-5-nitro-1H-imidazole
Tinidazole impurity B 1-(2-ethylsulphonylethyl)-2-methyl-4-nitroimidazole
Tinzaparin sodium
Tioconazole - Reference Spectrum
Tioconazole for system suitability
Tiotropium bromide monohydrate
Tiotropium impurity F dithiophen-2-ylmethanone
Tiotropium impurity mixture
Tiotropium for system suitability
Tobramycin
Tobramycin for identification
All-rac-alpha-tocopherol for peak identification
All-rac-alpha-tocopheryl acetate for peak identification
alpha-Tocopherol
alpha-Tocopheryl acetate
RRR-alpha-Tocopheryl hydrogen succinate
Tolbutamide
Tolfenamic acid
Tolnaftate
Tolnaftate for system suitability
Torasemide anhydrous
Torasemide for system suitability
Torasemide impurity E ethyl [[4-[(3-methylphenyl)amino]pyridin-3-yl]sulfonyl]carbamate
Tramadol hydrochloride
Tramadol impurity A (1RS,2SR)-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol
Tramadol impurity E (2RS)-2-[(dimethylamino)methyl]cyclohexanone
Tramazoline hydrochloride monohydrate
Tramazoline impurity A N-(naphthalen-1-yl)-4,5-dihydro-1H-imidazol-2-amine
Tramazoline impurity B mixture of: 1-acetyl-2-[(5,6,7,8-tetrahydronaphthalen-1-yl)amino]-4,5-dihydro-1H-imidazole and N-(4,5-dihydro-1H-imidazol-2-yl)-N-(5,6,7,8-tetrahydronaphthalen-1-yl)acetamide
Trandolapril
Trandolapril impurity C (2S,3aR,7aS)-1-[(2S)-2-[[(1S)-3-cyclohexyl-1- (ethoxycarbonyl)propyl]amino]propanoyl]octahydro-1H-indole-2-carboxylic acid (hexahydrotrandolapril)
Trandolapril impurity D ethyl (2S)-2-[(3S,5aS,9aR,10aS)-3-methyl-1,4-dioxodecahydropyrazino[1,2-a]indol-2(1H)-yl]- 4-phenylbutanoate (trandolapril diketopiperazine)
Tranexamic acid
Trapidil
10 mg
unit
5.045 mg
100 mg
20 mg
100 mg
10 mg
20 mg
250 mg
unit
50 mg
10 mg
10 mg
0.08 mg
10 mg
51 mg
250 mg
15 mg
30 mg
500 mg
500 mg
150 mg
100 mg
100 mg
60 mg
10 mg
10 mg
5 mg
0.0006 mg
75 mg
15 mg
15 mg
20 mg
10 mg
10 mg
EPY0000501
EPY0000495
10 mg
10 mg
EPY0000496 10 mg
EPT1810000
EPT1820000
50 mg
50 mg
304 Looking for impurity reference standards with CofAs? See our impurity chapter from page 11 on. Edition 2012/2013
Table of content
European Pharmacopoeia
Code Product Unit
EPT1820002
EPT1820004
EPY0001172
EPT1850000
EPT1899000
EPG0400010
EPT1899990
EPT1900000
New EPY0001459
EPT1950000
EPY0000050
EPY0000837
EPY0000870
EPT1975000
EPY0000165
EPY0000166
EPY0001055
EPY0000279
EPY0000799
EPT1977990
EPT1977995
EPT1978000
EPY0000111
EPT1985000
EPT1986000
EPT2000000
EPT2005000
EPT2005010
EPY0000720
EPY0000108
EPY0000068
EPT2009000
EPY0001260
EPY0001319
EPY0000092
EPY0000093
EPT2100000
EPT2200000
EPY0000684
EPT2200010
EPT2450000
EPT2500000
EPY0000759
EPT2500100
EPT2501200
Trapidil impurity A 5-methyl-[1,2,4]triazolo[1,5-a]pyrimidin-7-ol
Trapidil impurity B 1,2,4-triazol-3-amine
Trehalose dihydrate
Tretinoin
3,4,6-Tri-O-acetyl-D-glucal - Reference Spectrum
Triacetin - Reference Spectrum
Triamcinolone
Triamcinolone acetonide
Triamcinolone acetonide for system suitability
Triamcinolone hexacetonide
Triamcinolone impurity C 9-fluoro-11ß-16alpha,17,21-tetrahydroxypregn-4-ene-3,20-dione
Triamterene
Triamterene impurity B 2,7-diamino-6-phenylpteridin-4-ol
Triazolam Controlled Substance
Tribenoside
Tribenoside impurity A 3,5,6-tri-O-benzyl-1,2-O-(1-methylethylidene)-α-D-glucofuranose
Tributyl acetylcitrate
Tri-n-butyl phosphate
Tributyl acetylcitrate for peak identification
Tricaprin
Tricaproin
Tricaprylin
Trichloroacetic acid - Reference Spectrum
Trichlorotrifluoroethane
Triethyl citrate - Reference Spectrum
Trifluoperazine hydrochloride
Triflusal
Triflusal impurity B 2-hydroxy-4-(trifluoromethyl)benzoic acid
Triglycerol diisostearate
Trihexyphenidyl hydrochloride
Trihexyphenidyl impurity A 1-phenyl-3-(piperidin-1-yl)propan-1-one