Accelerated Stability Studies of Widely Used Pharmaceutical Substances Under Simulated Tropical Conditions
(1986; 119 pages) View the PDF document
Table of Contents
View the document1. Introduction
View the document2. Index of degradable substances
View the document3. Index of substances resistant to degradation
Close this folder4. Stability experiments on degradable substances
View the documentAcetylsalicylic acid
View the documentAminophylline
View the documentAmitriptyline hydrochloride
View the documentAmmonium chloride
View the documentAmphotericin B
View the documentAmpicillin sodium
View the documentAmpicillin trihydrate
View the documentAntimony sodium tartrate
View the documentAscorbic acid
View the documentBacitracin
View the documentBacitracin zinc
View the documentBenzathine benzylpenicillin
View the documentBenzylpenicillin potassium
View the documentBenzylpenicillin sodium
View the documentBephenium hydroxynaphthoate
View the documentCalcium gluconate
View the documentCalcium para-aminosalicylate
View the documentCarbenicillin sodium
View the documentCefalexin
View the documentChloral hydrate
View the documentChloramphenicol sodium succinate
View the documentChlorphenamine hydrogen maleate
View the documentChlorpromazine hydrochloride
View the documentChlortetracycline hydrochloride
View the documentCloxacillin sodium (monohydrate)
View the documentCoal tar (washed)
View the documentCodeine phosphate
View the documentColecalciferol
View the documentCresol
View the documentDapsone
View the documentDexamethasone sodium phosphate
View the documentDicloxacillin sodium (monohydrate)
View the documentDiethylcarbamazine dihydrogen citrate
View the documentDoxycycline hyclate
View the documentEmetine hydrochloride
View the documentEphedrine
View the documentEphedrine sulfate
View the documentEpinephrine
View the documentEpinephrine hydrogen tartrate
View the documentErgocalciferol
View the documentErgometrine hydrogen maleate
View the documentErgotamine maleate
View the documentErgotamine tartrate
View the documentEthosuximide
View the documentEthylmorphine hydrochloride
View the documentFerrous sulfate
View the documentFluphenazine decanoate
View the documentFluphenazine hydrochloride
View the documentFormaldehyde solution
View the documentGentamicin sulfate
View the documentGuanethidine sulfate
View the documentHexylresorcinol
View the documentHydralazine hydrochloride
View the documentHydrocortisone sodium succinate
View the documentHydroxocobalamin
View the documentHyoscyamine sulfate
View the documentImipramine hydrochloride
View the documentIpecacuanha powder
View the documentIsoprenaline hydrochloride
View the documentIsoprenaline sulfate
View the documentLidocaine hydrochloride
View the documentMelarsoprol
View the documentMercuric oxide yellow
View the documentMetrifonate
View the documentNaloxone hydrochloride
View the documentNeomycin sulfate
View the documentNystatin
View the documentOrciprenaline sulfate
View the documentOxytetracycline hydrochloride
View the documentParomomycin sulfate
View the documentPenicillamine
View the documentPethidine hydrochloride
View the documentPhenobarbital sodium
View the documentPhenoxymethylpenicillin
View the documentPhenoxymethylpenicillin calcium
View the documentPhenoxymethylpenicillin potassium
View the documentPhentolamine mesilate
View the documentPhenylbutazone
View the documentPilocarpine hydrochloride
View the documentPilocarpine nitrate
View the documentProcainamide hydrochloride
View the documentProcaine benzylpenicillin
View the documentProcaine hydrochloride
View the documentProcarbazine hydrochloride
View the documentPromazine hydrochloride
View the documentPromethazine hydrochloride
View the documentPyridoxine hydrochloride
View the documentQuinine bisulfate
View the documentQuinine dihydrochloride
View the documentRetinol (Vitamin A)
View the documentSalbutamol sulfate
View the documentSenna leaf
View the documentSilver nitrate
View the documentSodium calcium edetate
View the documentSodium lactate
View the documentSodium nitrite
View the documentSodium para-aminosalicylate
View the documentSodium stibogluconate
View the documentSulfacetamide sodium
View the documentSulfadiazine sodium
View the documentSulfadimidine sodium
View the documentSuxamethonium chloride
View the documentTetracaine hydrochloride
View the documentTetracycline hydrochloride
View the documentThiamine hydrochloride
View the documentThiamine mononitrate
View the documentThiopental sodium
View the documentTolbutamide
View the documentUndecylenic acid
View the documentWarfarin sodium
 

Chloramphenicol sodium succinate

Accelerated Degradation Experiment

Conditions

Procedure A:

30 days exposure at 50 °C and 100% relative humidity.

Procedure B:

30 days exposure at 50 °C and 100% relative humidity followed by 5 days at 70 °C and 100% relative humidity.

Appearance of the substance

The substance, originally in the form of a white to very pale yellow powder changes after procedure A into a pale yellow liquid and upon cooling turning into a heterogenous pale yellow liquid. After procedure B the colour turns to ochre yellow.

Gain of moisture

After procedures A and B: about 50%

Chromatographic test

Adsorbent: Silica gel 60 F-254

Solution applied to the plate: Substance dissolved in methanol.

Solvent system:

chloroform: ............................6 volumes
methanol: ...............................4 volumes

Development conditions:

The solvent is allowed to migrate until the front reaches a line 15 cm from the starting line.

Detection:

The plate is examined under ultraviolet light at a wavelength of maximum output at about 254 nm, and then sprayed successively with a solution of titanium trichloride, and with dimethylaminobenzaldehyde or dimethylaminocinnamaldehyde dissolved in diluted hydrochloric acid. The plate is examined at about 365 nm.

Results: The reference solution of chloramphenicol sodium succinate shows two main spots corresponding to the two isomers of esterification in positions 1 and 3, as well as a weak spot corresponding to chloramphenicol. The solutions of each of the samples subjected to procedures A and B show diminished main spots and three additional spots. The spot corresponding to chloramphenicol increases first and diminishes gradually.

Ultraviolet spectrophotometry

Aqueous solutions of the samples subjected to procedures A and B show no modification of the absorption wavelength but the absorbances increase with time.

Gas-liquid chromatography

After procedures A and B, the peaks corresponding to the 2 isomers decrease considerably due to the hydrolysis of the ester; the formed chloramphenicol degrades and several degradation products appear as separate peaks.

Conclusion

Chloramphenicol sodium succinate is subject to decomposition under accelerated degradation conditions.

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