Module 3 2019
A Question on Drug Purity
➢ Batch A Potency 99.9 area % Individual related
➢ Batch B Potency 97.5 area % Individual related substances 1 0.8 area % 2 1.5 area % 3 0.5 area % Others 0.1 – 0.3 area %
substances < 0.05 area % each Total related substances < 0.05 area %
Batch B gives better exposure to potential impurities - qualification
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