WitrynaICH M7: Mutagenic impurity management expectations. Including evaluation of changes to manufacturing for impact on the quality of drug substance and drug product. Process and controls assessed at approval and through subsequent change. • Other ICH Impurity Guidances • Q3A and B - Impurity management expectations for non … WitrynaTERGITOL™ 15-S-7 Surfactant. A secondary alcohol ethoxylate that is readily biodegradable, excellent wetting ability and non-APE based. It can be used in oilfield drilling and production formulations.
M4Q: The CTD — Quality - Food and Drug Administration
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ICH Q3B (R2) Impurities in new drug products - Scientific guideline
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