Quality Assurance of Pharmaceuticals - A Compendium of Guidelines and Related Materials - Volume 1
(1997; 248 pages) [French] View the PDF document
Table of Contents
Open this folder and view contentsIntroduction
Open this folder and view contents1. National drug regulation
Open this folder and view contents2. Product assessment and registration
Open this folder and view contents3. Distribution
Close this folder4. The international pharmacopoeia and related activities
View the documentGuidance for those preparing or commenting on monographs for preparations to be included in The international pharmacopoeia1
View the documentValidation of analytical procedures used in the examination of pharmaceutical materials1
Open this folder and view contentsGeneral guidelines for the establishment, maintenance, and distribution of chemical reference substances1
View the documentGeneral recommendations for the preparation and use of infrared spectra in pharmaceutical analysis1
View the documentList of available International Chemical Reference Substances1
View the documentList of available International Infrared Reference Spectra1
Open this folder and view contents5. Basic tests
Open this folder and view contents6. Laboratory services
Open this folder and view contents7. International trade in pharmaceuticals
Open this folder and view contents8. Counterfeit products
Open this folder and view contents9. Training
View the documentSelected WHO publications of related interest
View the documentBack cover
 

List of available International Chemical Reference Substances1

1WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-fourth Report. Geneva, World Health Organization, 1996 (WHO Technical Report Series, No. 863).

International Chemical Reference Substances 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.

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

International Chemical Reference Substances 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 their use.

It is generally recommended that the substances 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.

The stability of the International Chemical Reference Substances kept at the Collaborating Centre is monitored by regular re-examination, and materials that have deteriorated are replaced by new batches when necessary. Lists giving control numbers for the current batches are issued in the annual reports from the Centre and may be obtained on request.

Orders for International Chemical Reference Substances should be sent to:

WHO Collaborating Centre for Chemical Reference Substances
Apoteksbolaget AB
Centrallaboratoriet
S-105 14 Stockholm
Sweden
Telex: 115 53 APOBOL S
Fax: 46 8 740 60 40

International Chemical Reference Substances are supplied only in the standard packages indicated in the following list.

Reference substance

Package
size

   

aceclidine salicylate

100 mg

p-acetamidobenzalazine

100 mg

acetazolamide

100 mg

allopurinol

100 mg

2-amino-5-nitrothiazole

25 mg

3-aminopvrazole-4-carboxamide hemisulfate

100 mg

amitriptyline hydrochloride

100 mg

amodiaquine hvdrochloride

200 mg

amphotericin B

400 mg

ampicillin (anhydrous)

200 mg

ampicillin sodium

200 mg

ampicillin trihydrate

200 mg

anhydrotetracycline hydrochloride

25 mg

atropine sulfate

100 mg

azathioprine

100 mg

   

bacitracin zinc

200 mg

beclometasone dipropionate

200 mg

bendazol hydrochloride

100 mg

benzobarbital

100 mg

benzylamine sulfate

100 mg

benzylpenicillin potassium

200 mg

benzylpenicillin sodium

200 mg

bephenium hydroxynaphthoate

100 mg

betamethasone

100 mg

betamethasone valerate

100 mg

betanidine sulfate

100 mg

bupivacaine hydrochloride

100 mg

   

caffeine

100 mg

carbamazepine

100 mg

carbenicillin monosodium

200 mg

chloramphenicol

200 mg

chloramphenicol palmitate

1 g

chloramphenicol palmitate (polymorph A)

200 mg

5-chloro-2-methylaminobenzophenone

100 mg

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

50 mg

chlorphenamine hydrogen maleate

100 mg

chlorpromazine hydrochloride

100 mg

chlortalidone

100 mg

chlortetracycline hydrochloride

200 mg

cimetidine

100 mg

clomifene citrate

100 mg

clomifene citrate Z-isomer (see zuclomifene)

 

cloxacillin sodium

200 mg

colecalciferol (vitamin D3)

500 mg

cortisone acetate

100 mg

   

dapsone

100 mg

desoxycortone acetate

100 mg

dexamethasone

100 mg

dexamethasone acetate

100 mg

dexamethasone phosphoric acid

100 mg

dexamethasone sodium phosphate

100 mg

diazepam

100 mg

diazoxide

100 mg

dicloxacillin sodium

200 mg

dicolinium iodide

100 mg

dicoumarol

100 mg

diethylcarbamazine dihydrogen citrate

100 mg

digitoxin

100 mg

digoxin

100 mg

N,N’-di-(2,3-xylyl)anthranilamide

50 mg

dopamine hydrochloride

100 mg

   

emetine hydrochloride

100 mg

4-epianhydrotetracycline hydrochloride

25 mg

4-epitetracycline hydrochloride

25 mg

ergocalciferol (vitamin D2)

500 mg

ergometrine hydrogen maleate

50 mg

ergotamine tartrate

50 mg

erythromycin

250 mg

estradiol benzoate

100 mg

estrone

100 mg

etacrynic acid

100 mg

ethambutol hydrochloride

100 mg

ethinylestradiol

100 mg

ethisterone

100 mg

ethosuximide

100 mg

etocarlide

100 mg

   

flucytosine

100 mg

fluorouracil

100 mg

fluphenazine decanoate dihydrochloride

100 mg

fluphenazine enantate dihydrochloride

100 mg

fluphenazine hydrochloride

100 mg

folic acid

100 mg

3-formylrifamycin

200 mg

framycetin sulfate (neomycin B sulfate)

200 mg

furosemide

100 mg

griseofulvin

200 mg

   

haloperidol

100 mg

hydrochlorothiazide

100 mg

hydrocortisone

100 mg

hydrocortisone acetate

100 mg

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

25 mg

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

25 mg

ibuprofen

100 mg

imipramine hydrochloride

100 mg

indometacin

100 mg

o-iodohippuric acid

100 mg

isoniazid

100 mg

lanatoside C

100 mg

levodopa

100 mg

levothyroxine sodium

100 mg

lidocaine

100 mg

lidocaine hydrochloride

100 mg

liothyronine sodium

50 mg

   

mefenamic acid

100 mg

melting point reference substances

 
 

azobenzene (69 °C)

4g

 

vanillin (83 °C)

4g

 

benzil (96 °C)

4g

 

acetanilide (116 °C)

4g

 

phenacetin (136 °C)

4g

 

benzanilide (165 °C)

4g

 

sulfanilamide (166 °C)

4g

 

sulfapyridine (193 °C)

4g

 

dicyanodiamide (210 °C)

4g

 

saccharin (229 °C)

4g

 

caffeine (237 °C)

4g

 

phenolphthalein (263 °C)

4g

metazide

100 mg

methaqualone

100 mg

methyldopa

100 mg

methyltestosterone

100 mg

meticillin sodium

200 mg

metronidazole

100 mg

   

nafcillin sodium

200 mg

neamine hydrochloride (neomycin A hydrochloride)

0.5 mg

neostigmine metilsulfate

100 mg

nicotinamide

100 mg

nicotinic acid

100 mg

niridazole

200 mg

niridazole-chlorethylcarboxamide

25 mg

norethisterone

100 mg

norethisterone acetate

100 mg

nystatin

200 mg

   

ouabain

100 mg

oxacillin sodium

200 mg

oxytetracycline dihydrate

200 mg

oxytetracycline hydrochloride

200 mg

   

papaverine hydrochloride

100 mg

pheneticillin potassium

200 mg

phenoxymethylpenicillin

200 mg

phenoxymethylpenicillin calcium

200 mg

phenoxymethylpenicillin potassium

200 mg

phenytoin

100 mg

prednisolone

100 mg

prednisolone acetate

100 mg

prednisone

100 mg

prednisone acetate

100 mg

probenecid

100 mg

procaine hydrochloride

100 mg

procarbazine hydrochloride

100 mg

progesterone

100 mg

propicillin potassium

200 mg

propranolol hydrochloride

100 mg

propylthiouracil

100 mg

pyrantel embonate

500 mg

pyridostigmine bromide

100 mg

   

reserpine

100 mg

retinol acetate (solution)

5 capsules1

riboflavin

250 mg

rifampicin

200 mg

rifampicin quinone

200 mg

   

sodium cromoglicate

100 mg

spectinomycin hydrochloride

200 mg

sulfamethoxazole

100 mg

sulfamethoxypyridazine

100 mg

sulfanilamide

100 mg

sulfasalazine

100 mg

   

testosterone propionate

100 mg

tetracycline hydrochloride

200 mg

thioacetazone

100 mg

4,4’-thiodianiline

50 mg

L-thyroxine sodium see levothyroxine sodium

 

tolbutamide

100 mg

tolnaftate

100 mg

trimethadione

200 mg

trimethoprim

100 mg

trimethylguanidine sulfate

100 mg

tubocurarine chloride

100 mg

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

 

vincristine sulfate

9.7 mg/vial

warfarin

100 mg

zuclomifene

50 mg

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

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