Abstract
AbstractA novel technique for depyrogenation of high molecular weight drugs sensitive to heat, acids, alkalies and chemical agents was developed on laboratory scale using sterile immobilized ∞ -amylase. Pyrogenic solution of drug was aseptically treated with immobilized enzyme in the presence of 0.05 % v/v chloroform as a preservative for specific period of time under optimum conditions of temperature, pH and agitation. After a definite period, the drug solution was separated from immobilized enzyme aseptically and heated under vacuum to remove the volatile preservative. Significant decrease in the pyrogenic content of drug solution was observed when tested in rabbits for the presence of pyrogens before and after treatment with sterile immobilized enzyme. The time required for complete depyrogenation was found to be a function of the amount of pyrogens present in the drug. Dry, apyrogenic drug can be recovered from drug solution by suitable means.
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