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AMRI Offers Stand-Alone Impurity Services

New regulatory requirements drive increase in analytical testing services

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By: Kristin Brooks

Managing Editor, Contract Pharma

AMRI is now offering its impurity services as a stand-alone service. New regulatory requirements for drug products, including the finalization of ICH M7 earlier this year and the upcoming compliance of USP 232 and USP 233 by January 1, 2018, has led to an increase in analytical testing. ICH M7 provides a framework for the identification, categorization, qualification, and control of mutagenic impurities to limit potential carcinogenic risk and USP 232 and USP 233 provides direction related to El...

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