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Full article: Effect of impurity on dissolution behavior of simulated ...
WitrynaThis document provides guidance on the content and qualification of impurities in new drug products for registration applications. It applies to drug products produced from chemically synthesised new drug substances not previously registered in a region or Member State. Keywords: Finished product, impurities, reporting, control, … WitrynaThe European Medicines Agency's scientific guidelines on impurities in drug products and drug substances help medicine developers prepare marketing authorisation … pom christian academy
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