Stability of Drugs in Aqueous Solutions. II. Application of Weibull Probability Paper to Predictions of Coloration of Parenteral Solutions

概要

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For the quality control of drug products, it is usually necessary to predict the coloration of parenteral solutions under marketing conditions. This paper presents a new method for the prediction of coloration of parenteral solutions using as examples thiamine hydrochloride injection, reserpine injection, ascorbic acid injection and ATP injection. The time course of decrease of percent transmittance at 430 nm for each parenteral solution was measured spectrophotometrically. When the decreases at elevated temperatures were plotted against time on Weibull probability paper, straight lines were obtained at all temperatures. The temperature dependence of the decrease in each parenteral solution was obtained as a straight regression line on plotting (1/m) In k vs. 1/T. The predicted decreases of percent transmittance for each parenteral solution at 25℃ were in good agreement with those observed at 25℃ except in the case of reserpine injection. Thus, this method proved to be satisfactory for the quality control of the other three injections and may also be applicable to other injections.
公益社団法人日本薬学会の論文
1981-12-25