Pharmaceutical Product-related Substance
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Pharmaceutical Product-related Substance Definition
Molecular variants of the desired biological product formed during manufacture and/or storage, which are active and have no deleterious effect on the safety and efficacy of the drug substance or drug product. These variants possess properties comparable to the desired product and are not considered impurities.
Pharmaceutical Product-related Substance Synonyms
Pharmaceutical Product-related Substance
Terms in Pharmaceutical Product-related Substance category
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