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QUALITY CONTROL 2 LEC

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Question:

Where a new drug substance is predominantly one enantiomer, the opposite enantiomer is excluded from the qualification and identification thresholds given in the ICH Guidelines on Impurities in New Drug Substances and Impurities in New Drug Products because of practical difficulties in quantifying it at those levels.

Author: LEIGHTON DWIGHT OBILLOS



Answer:

Tests for chiral new drug substances


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