QUALITY CONTROL 2 LEC: For a racemic drug substance, there are generally two situations where
a stereospecific identity test is appropriate for release/acceptance testing:

Question

For a racemic drug substance, there are generally two situations where
a stereospecific identity test is appropriate for release/acceptance testing:

LEIGHTON DWIGHT OBILLOS · Accepted Answer

1) where there is a significant possibility that the ENANTIOMER might be SUBSTITUTED for the RACEMATE

2) when there is evidence that PREFERENTIAL CRYSTALLIZATION may lead to unintentional production of a NON-RACEMIC MIXTURE

For a racemic drug substance, there are generally two situations where a stereospecific identity test is appropriate for release/acceptance testing: