Abstract
AbstractThis report describes results of a collaborative study in which samples of the 5 mg strength of prednisone tablets were evaluated following a common protocol based on European (Ph. Eur.) and US Pharmacopeial (USP) specifications. Several tests including, identification, content uniformity and dissolution were performed. Laboratories from 16 countries submitted data representing 42 products obtained from the respective local markets. There were no reported abnormalities in general appearance and identification of the products evaluated. Most products met the requirements for assay and content uniformity. Dissolution results showed that 11 lots did not meet the USP S1 stage Tolerance Criterion, whereas products from Greece (one lot) and Sweden (two lots) would not meet the dissolution requirement of USP even at the S3 stage, i.e. these lots would be rejected. Overall variability (% CV) in percent drug release values at different sampling times for the tested products and those of USP calibrator tabl...
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