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FAQs

Why does the API for Crystal Structures Screening Require Sample Purity?

Impurities can affect their dynamic stability in solution and suspension by affecting nucleation and growth rates. Therefore, the screening of polymorph with earlier batches of APIs still containing many impurities may yield different results than screening with later, purer batches. In unfortunate cases, significant forms may not be found in the initial screening. Therefore, it is recommended to repeat the polymorph screening at least several times for a batch of APIs with impurity characteristics of the product to be marketed produced by the final GMP procedure.