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