Stability of drugs in aqueous solutions. II. Application of weibull probability paper to predictions of coloration of parenteral solutions.

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Abstract
For the quality control of drug products, it is usually necessary to predict the coloration of parenteral solutions under marketing conditions. A new method for the prediction of coloration of parenteral solutions using as examples thiamine hydrochloride, reserpine, ascorbic acid and ATP is described. 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. The predicted decreases of percent transmittance for each parenteral solution at 25.degree. C were in good agreement with those observed at 25.degree. C, except in the case of reserpine. This method was satisfactory for the quality control of the other 3 injections and may also be applicable to others.

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