If an active pharmaceutical ingredient (API) has an amorphous crystal form, is it necessary to provide analysis results for its crystal form?

刊登日期:2020-07-22  |  點閱次數 : 1044 次 

Yes, because conversion from the amorphous form to crystalline form may take place unless relevant reference articles has  been provided to demonstrate amorphous form stability. Crystal form analysis results for at least three consecutive batches of active pharmaceutical ingredient (API) and crystal form analysis results from a stability study with a study period sufficient to cover the proposed re-test period of the API should be provided.



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