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
Close this folder2. Product assessment and registration
View the documentGuidelines for the assessment of herbal medicines1,2
Close this folderStability of drug dosage forms1
View the document1. Introduction
View the document2. General considerations
Open this folder and view contents3. Responsibility of parties involved in the assurance of drug stability
View the document4. Use of terms
View the document5. Less stable drug substances
View the documentReferences
Open this folder and view contentsGuidelines for stability testing of pharmaceutical products containing well established drug substances in conventional dosage forms1
Open this folder and view contentsMultisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability1
Open this folder and view contents3. Distribution
Open this folder and view contents4. The international pharmacopoeia and related activities
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

5. Less stable drug substances

The experimental conditions used to compile this list of less stable substances were the following: initial exposure for 30 days to air at 50 °C and 100% humidity; if no degradation was demonstrable after this time, the temperature was raised to 70 °C for a further period of 3 - 7 days. All other factors being equal, finished products containing the following substances require particular attention from the stability viewpoint.1

1 For the report of the study on which this list is based, see Accelerated stability studies of widely used pharmaceutical substances under simulated tropical conditions. Geneva, World Health Organization, 1986 (unpublished document WHO/PHARM/86.529; available oh request from Quality Assurance, Division of Drug Management and Policies, World Health Organization, 1211 Geneva 27, Switzerland).

acetylsalicylic acid
amitriptyline hydrochloride
ammonium chloride
amphotericin B
ampicillin sodium
ampicillin trihydrate
antimony sodium tartrate
ascorbic acid

bacitracin zinc
benzathine benzylpenicillin
benzylpenicillin potassium
benzylpenicillin sodium
bephenium hydroxynaphthoate

calcium gluconate
calcium para-aminosalicylate
carbenicillin sodium
chloral hydrate
chloramphenicol sodium succinate
chlorphenamine hydrogen maleate
chlorpromazine hydrochloride
chlortetracycline hydrochloride
cloxacillin sodium (monohydrate)
codeine phosphate

dexamethasone sodium phosphate
dicloxacillin sodium (monohydrate)
diethylcarbamazine dihydrogen citrate
doxycycline hyclate

emetine hydrochloride
ephedrine sulfate
epinephrine hydrogen tartrate
ergometrine hydrogen maleate
ergotamine maleate
ergotamine tartrate
ethylmorphine hydrochloride

ferrous sulfate
fluphenazine decanoate
fluphenazine hydrochloride
formaldehyde solution

gentamicin sulfate
guanethidine sulfate

hydralazine hydrochloride
hydrocortisone sodium succinate
hyoscyamine sulfate

imipramine hydrochloride
ipecacuanha powder
isoprenaline hydrochloride
isoprenaline sulfate

lidocaine hydrochloride

mercuric oxide yellow

naloxone hydrochloride
neomycin sulfate

orciprenaline sulfate
oxytetracyline hydrochloride

paromomycin sulfate
pethidine hydrochloride
phenobarbital sodium
phenoxymethylpenicillin calcium
phenoxymethylpenicillin potassium
phentolamine mesilate
pilocarpine hydrochloride
pilocarpine nitrate
procainamide hydrochloride
procaine benzylpenicillin
procaine hydrochloride
procarbazine hydrochloride
promazine hydrochloride
promethazine hydrochloride
pyridoxine hydrochloride

quinine bisulfate
quinine dihydrochloride

retinol (vitamin A)

salbutamol sulfate
senna leaf
silver nitrate
sodium calcium edetate
sodium lactate
sodium nitrite
sodium para-aminosalicylate
sodium stibogluconate
sulfacetamide sodium
sulfadiazine sodium
sulfadimidine sodium
suxamethonium chloride

tetracaine hydrochloride
tetracycline hydrochloride
thiamine hydrochloride
thiamine mononitrate
thiopental sodium

undecylenic acid

warfarin sodium

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