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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