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AMRI Offers Stand-Alone Impurity Services


New regulatory requirements drive increase in analytical testing services

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 Elemental Impurities-Limits and Procedures.

AMRI offers a systematic service to help customers determine and quantify the impact of potential genotoxic impurities (PGI) and elemental impurities on the safety of a drug through toxicological risk assessments to mitigate downstream product risk. This helps ensure control of the right target analytes with accurate identification and appropriate specification setting.
AMRI applies high resolution mass spectrometry (HRMS) with liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS) technology, as well as gas chromatography mass spectrometry (GC-MS); Orbitrap Q-Exactive LC-MS, providing both HRMS and high-resolution, accurate-mass (HRAM); and inductively coupled plasma mass spectrometry (ICP-MS).
“Offering our impurity solutions as a stand-alone service – beyond providing them as an accompanying service to AMRI’s Discovery & Development services, or API and Drug Product programs – will enable us to extend our comprehensive expertise, purpose-built technologies and resources to our customers for impurity assessments and control,” said John Iannone, director, extractables/leachables and impurities, AMRI.