CONTROL OF CCI-779 DOSAGE FORM STABILITY THROUGH CONTROL OF DRUG SUBSTANCE IMPURITIES

摘要

A method of preparing a rapamycin composition having increased potency is provided. The method involves selecting a rapamycin compound having less than 1.5% oxidative and hydrolytic rapamycin impurities and formulating the selected rapamycin with an antioxidant and optional excipients.