Various techniques for the routine evaluation of the degradation of glucose in parenteral solutions--a critical study.
A practical approach is described for studying the influence of various physicochemical factors on the degradation of glucose in parenteral solutions sterilized by heating in an autoclave. Five routine analytical methods are discussed: pH determination; direct ultraviolet absorption measurement (BP) method; liquid chromatography of 5-HMF; thin-layer chromatography of sugars, carboxylic acids and carbonyl species; and enzymatic determination of glucose. The effects of various factors on the degradation of glucose were studied: glucose concentration (10%, 30%, 50%); pH of solution before sterilization (2-10); sterilization cycle (103 min at 110 degrees C, 20 min at 120 degrees C, 3 min at 134 degrees C; same Fo); time of heating at 120 degrees C (30, 40, 60 min); and the presence of salts (sodium acetate, sodium lactate, sodium chloride). The results demonstrate the importance of these factors in influencing the rate of glucose degradation during sterilization. In the presence of salts, 5-HMF is not the most important product of degradation and the BP assay is not suitable for evaluation of glucose breakdown. The authors propose two control procedures. For simple solutions of glucose, the BP method is suitable. In the presence of salts the glucose oxidase method should be used.
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Laboratoire de contrôle de qualité de la Pharmacie centrale des hôpitaux de Paris, 7 rue du Fer à Moulin, 75221 Paris cedex 05, France.
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F
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Pradeau
D
D
Matchoutsky
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Prognon
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Hamon
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