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WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 885 - Thirty-fifth Report
(1999; 168 pages) [Spanish] View the PDF document
Table of Contents
View the documentWHO Expert Committee on Specifications for Pharmaceutical Preparations
View the document1. Introduction
Open this folder and view contents2. The international pharmacopoeia and related issues
Open this folder and view contents3. International Chemical Reference Substances and Infrared Reference Spectra
Open this folder and view contents4. Quality control - national laboratories
Open this folder and view contents5. Good manufacturing practices
Open this folder and view contents6. Quality systems and inspection
Open this folder and view contents7. Other quality assurance topics
Open this folder and view contents8. Nomenclature and terminology
Open this folder and view contents9. Legal aspects of pharmaceuticals
Open this folder and view contents10. Regulatory issues
Open this folder and view contents11. Training activities
View the document12. Pharmaceuticals contaminated with diethylene glycol
View the documentAcknowledgements
View the documentReferences
View the documentAnnex 1. List of available International Chemical Reference Substances1
View the documentAnnex 2. List of available International Infrared Reference Spectra1
Open this folder and view contentsAnnex 3. General guidelines for the establishment, maintenance and distribution of chemical reference substances
Open this folder and view contentsAnnex 4. Good manufacturing practices: authorized person - role, functions and training
Open this folder and view contentsAnnex 5. Good manufacturing practices: supplementary guidelines for the manufacture of pharmaceutical excipients
Open this folder and view contentsAnnex 6. Guidelines for inspection of drug distribution channels
View the documentAnnex 7. Good pharmacy practice in community and hospital pharmacy settings
Open this folder and view contentsAnnex 8. National drug regulatory legislation: guiding principles for small drug regulatory authorities
Open this folder and view contentsAnnex 9. Provisional guidelines for developing training programmes: inspection and examination of counterfeit pharmaceuticals
View the documentWorld Health Organization Technical Report Series
View the documentSelected WHO Publications of Related Interest
View the documentBack Cover
 

Annex 1. List of available International Chemical Reference Substances1

1 As updated at the thirty-fifth meeting of the WHO Expert Committee on Specifications for Pharmaceutical Preparations, 21-25 April 1997.

 

International Chemical Reference Substances (ICRS) are established on the advice of the WHO Expert Committee on Specifications for Pharmaceutical Preparations. They are supplied primarily for use in physical and chemical tests and assays described in the specifications for quality control of drugs published in The international pharmacopoeia or proposed in draft monographs. The ICRS are mainly intended to be used as primary standards to calibrate secondary standards.

Directions for use, and analytical data required for the use described in the relevant specifications of The international pharmacopoeia, are given in the certificates enclosed with the substances when distributed. More detailed analytical reports on the substances may be obtained from the WHO Collaborating Centre for Chemical Reference Substances.

ICRS may also be used in tests and assays not described in The international pharmacopoeia. However, the responsibility for assessing the suitability of the substances then rests with the user or with the pharmacopoeia commission or other authority that has prescribed this use.

It is generally recommended that the substances should be stored protected from light and moisture and preferably at a temperature of about +5°C. When special storage conditions are required, this is stated on the label or in the accompanying leaflet. It is recommended that the user purchase only an amount sufficient for immediate use.

The stability of the ICRS kept at the Collaborating Centre is monitored by regular re-examination, and any material that has deteriorated is replaced by new batches when necessary. Lists giving control numbers for the current batches are issued in the annual reports from the Centre and new yearly lists may also be obtained on request.

Orders for the ICRS should be sent to:

WHO Collaborating Centre for Chemical Reference Substances
Apoteket AB
Produktion & Laboratorier Centrallaboratoriet, ACL
Prismavägen 2
S-141 75 Kungens Kurva
Sweden
(Telefax: +46 8 740 60 40)

 

The ICRS are supplied only in the standard packages indicated in the following list:

Reference substance

Package size

Control number

aceclidine salicylate

100 mg

172048

p-acetamidobenzalazine

100 mg

290042

acetazolamide

100 mg

186128

allopurinol

100 mg

287049

amidotrizoic acid

100 mg

196205

2-amino-5-nitrothiazole

25 mg

186131

3-aminopyrazole-4-carboxamide hemisulfate

100 mg

172050

3-amino-2,4,6-triiodobenzoic acid

100 mg

196206

amitriptyline hydrochloride

100 mg

181101

amodiaquine hydrochloride

200 mg

192160

amphotericin B

400 mg

191153

ampicillin (anhydrous)

200 mg

390001

ampicillin sodium

200 mg

388002

ampicillin trihydrate

200 mg

274003

anhydrotetracycline hydrochloride

25 mg

180096

atropine sulfate

100 mg

183111

azathioprine

100 mg

172060

     

bacitracin zinc

200 mg

192174

beclometasone dipropionate

200 mg

192175

bendazol hydrochloride

100 mg

173066

benzobarbital

100 mg

172051

benzylamine sulfate

100 mg

172052

benzylpenicillin potassium

200 mg

180099

benzylpenicillin sodium

200 mg

280047

bephenium hydroxynaphthoate

100 mg

183112

betamethasone

100 mg

183113

betamethasone sodium phosphate

100 mg

196203

betamethasone valerate

100 mg

190145

betanidine sulfate

100 mg

172053

bupivacaine hydrochloride

100 mg

289054

     

caffeine

100 mg

181102

calcium folinate (leucovorin calcium)

100 mg

194188

carbamazepine

100 mg

189143

carbenicillin monosodium

200 mg

383043

chloramphenicol

200 mg

486004

chloramphenicol palmitate

1 g

286072

chloramphenicol palmitate (polymorph A)

200 mg

175073

5-chloro-2-methylaminobenzophenone

100 mg

172061

chloroquine sulfate

200 mg

195201

2-(4-chloro-3-sulfamoylbenzoyl)benzoic acid

50 mg

181106

chlorphenamine hydrogen maleate

100 mg

182109

chlorpromazine hydrochloride

100 mg

178080

chlortalidone

100 mg

183114

chlortetracycline hydrochloride

200 mg

187138

cimetidine

100 mg

190150

clomifene citrate

100 mg

187136

clomifene citrate Z-isomer see zuclomifene

   

cloxacillin sodium

200 mg

274005

colecalciferol (vitamin D3)

500 mg

190146

cortisone acetate

100 mg

167006

     

dapsone

100 mg

183115

desoxycortone acetate

100 mg

167007

dexamethasone

100 mg

388008

dexamethasone acetate

100 mg

288009

dexamethasone phosphoric acid

100 mg

192161

dexamethasone sodium phosphate

100 mg

192158

diazepam

100 mg

172062

diazoxide

100 mg

181103

dicloxacillin sodium

200 mg

174071

dicolinium iodide

100 mg

172055

dicoumarol

100 mg

178077

diethylcarbamazine dihydrogen citrate

100 mg

181100

digitoxin

100 mg

277010

digoxin

100 mg

587011

N, N'-di-(2,3-xylyl) anthranilamide

50 mg

173067

dopamine hydrochloride

100 mg

192159

doxorubicin hydrochloride

100 mg

196202

     

emetine hydrochloride

100 mg

187134

4-epianhydrotetracycline hydrochloride

25 mg

288097

4-epitetracycline hydrochloride

25 mg

293098

ergocalciferol (vitamin D2)

500 mg

190147

ergometrine hydrogen maleate

50 mg

277012

ergotamine tartrate

50 mg

385013

erythromycin

250 mg

191154

erythromycin B

150 mg

194186

erythromycin C

25 mg

194187

estradiol benzoate

100 mg

167014

estrone

100 mg

279015

etacrynic acid

100 mg

281056

ethambutol hydrochloride

100 mg

179081

ethinylestradiol

100 mg

291016

ethisterone

100 mg

167017

ethosuximide

100 mg

179088

etocarlide

100 mg

172057

     

flucloxacillin sodium

200 mg

195194

flucytosine

100 mg

184121

fludrocortisone acetate

200 mg

195199

fluorouracil

100 mg

184122

fluphenazine decanoate dihydrochloride

100 mg

182107

fluphenazine enantate dihydrochloride

100 mg

182108

fluphenazine hydrochloride

100 mg

176076

folic acid

100 mg

388019

3-formylrifamycin

200 mg

190149

framycetin sulfate (neomycin B sulfate)

200 mg

193178

furosemide

100 mg

171044

     

gentamicin sulfate

100 mg

194183

griseofulvin

200 mg

280040

     

haloperidol

100 mg

172063

hydrochlorothiazide

100 mg

179087

hydrocortisone

100 mg

283020

hydrocortisone acetate

100 mg

280021

hydrocortisone sodium succinate

200 mg

194184

(-)-3-(4-hydroxy-3-methoxyphenyl)-2-hydrazino-2-methylalanine (3-O-methylcarbidopa)

25 mg

193180

(-)-3-(4-hydroxy-3-methoxyphenyl)-2-methylalanine (3-O-methylmethyldopa)

25 mg

179085

     

ibuprofen

100 mg

183117

imipramine hydrochloride

100 mg

172064

indometacin

100 mg

178078

o-iodohippuric acid

100 mg

171045

isoniazid

100 mg

185124

     

lanatoside C

100 mg

281022

levodopa

100 mg

295065

levonorgestrel

200 mg

194182

levothyroxine sodium

100 mg

189144

lidocaine

100 mg

181104

lidocaine hydrochloride

100 mg

181105

liothyronine sodium

50 mg

193179

loperamide hydrochloride

100 mg

194185

     

mebendazole

200 mg

195195

mefenamic acid

100 mg

173068

melting point reference substances

   
 

azobenzene

(69°C)

4g

192168

 

vanillin

(83°C)

4g

192169

 

benzil

(96°C)

4g

294170

 

acetanilide

(116°C)

4g

192171

 

phenacetin

(136°C)

4g

192172

 

benzanilide

(165°C)

4g

192173

 

sulfanilamide

(166°C)

4g

192162

 

sulfapyridine

(193°C)

4g

192163

 

dicyanodiamide

(210°C)

4g

192164

 

saccharin

(229°C)

4g

192165

 

caffeine

(237°C)

4g

192166

 

phenolphthalein

(263°C)

4g

192167

metazide

100 mg

172058

methaqualone

100 mg

173069

methotrexate

100 mg

194193

methyldopa

100 mg

179084

methyltestosterone

100 mg

167023

meticillin sodium

200 mg

274024

metronidazole

100 mg

183118

     

nafcillin sodium

200 mg

272025

neamine hydrochloride (neomycin A hydrochloride)

0.5 mg

193177

neomycin B sulfate see framycetin sulfate

   

neostigmine metilsulfate

100 mg

187135

nicotinamide

100 mg

179090

nicotinic acid

100 mg

179091

nifurtimox

100 mg

194189

niridazole

200 mg

186129

niridazole-chlorethylcarboxamide

25 mg

186130

norethisterone

100 mg

186132

norethisterone acetate

100 mg

185123

nystatin

200 mg

191152

     

ouabain

100 mg

283026

oxacillin sodium

200 mg

382027

oxytetracycline dihydrate

200 mg

189142

oxytetracycline hydrochloride

200 mg

189141

     

papaverine hydrochloride

100 mg

185127

paracetamol

100 mg

195198

paromomycin sulfate

75 mg

195197

pheneticillin potassium

200 mg

167028

phenoxymethylpenicillin

200 mg

179082

phenoxymethylpenicillin calcium

200 mg

179083

phenoxymethylpenicillin potassium

200 mg

176075

phenytoin

100 mg

179089

praziquantel

100 mg

194191

prednisolone

100 mg

389029

prednisolone acetate

100 mg

289030

prednisolone hemisuccinate

200 mg

195196

prednisolone sodium phosphate

200 mg

194190

prednisone

100 mg

167031

prednisone acetate

100 mg

169032

probenecid

100 mg

192156

procaine hydrochloride

100 mg

183119

procarbazine hydrochloride

100 mg

184120

progesterone

100 mg

167033

propicillin potassium

200 mg

274034

propranolol hydrochloride

100 mg

187139

propylthiouracil

100 mg

185126

pyrantel embonate (pyrantel pamoate)

500 mg

192157

pyridostigmine bromide

100 mg

182110

     

reserpine

100 mg

186133

retinol acetate (solution)

5 capsules1

791038

riboflavin

250 mg

382035

rifampicin

200 mg

191151

rifampicin quinone

200 mg

190148

     

sodium cromoglicate

100 mg

188140

spectinomycin hydrochloride

200 mg

193176

sulfacetamide

100 mg

196200

sulfamethoxazole

100 mg

179092

sulfamethoxypyridazine

100 mg

178079

sulfanilamide

100 mg

179094

sulfasalazine

100 mg

191155

     

tamoxifen citrate

100 mg

196208

tamoxifen citrate E-isomer

10 mg

196209

testosterone enantate

200 mg

194192

testosterone propionate

100 mg

167036

tetracycline hydrochloride

200 mg

180095

thioacetazone

100 mg

171046

4,4'-thiodianiline

50 mg

183116

thyroxine sodium see levothyroxine sodium

   

tolbutamide

100 mg

179086

tolnaftate

100 mg

176074

toluene-2-sulfonamide

100 mg

196204

trimethadione

200 mg

185125

trimethoprim

100 mg

179093

trimethylguanidine sulfate

100 mg

172059

tubocurarine chloride

100 mg

170037

     

vincristine sulfate

9.7 mg/vial

193181

vitamin A acetate (solution) see retinol acetate (solution)

   
     

warfarin

100 mg

168041

     

zuclomifene

50 mg

187137

1 Each containing about 9 mg in 250 mg of oil.

 

 

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