Q3 drug development - Q3B(R2 Impurities in New Drug Products This acts as a guide during the application process on impurities in a new drug product

Q3 drug development - Q3B(R2 Impurities in New Drug...

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Q3B(R2) Impurities in New Drug Products This acts as a guide during the application process on impurities in a new drug product produced from chemically synthesized new drug substances not previously registered. It only addresses impurities classified as degradation or reaction products of the drug substance with an immediate container closure system. Some products are excluded from this guidance, as well as contaminants that should not occur under GMP practices, polymorphic forms and enantiomeric impurities. Degradation products should be reported during the manufacture and stability studies of a new drug product. Potential degradation pathways arising from interaction with excipients or immediate container closure systems should be identified as well as a summary of degradation during laboratory degradation studies. if while testing for stability, degradation occurs while in recommended storage conditions, it should be identified in above identification thresholds. Or if unsuccessful as identifying,
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