AMRI, a contract research, development, and manufacturing organization, has launched impurity analytical testing as a stand-alone service.

AMRI’s service is designed to help customers determine and quantify the impact of potential genotoxic impurities and elemental impurities on the safety of a drug through toxicological risk assessments to mitigate downstream product risk.

The company is applyings 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, and Orbitrap Q-Exactive liquid chromatography-mass spectrometry (LC-MS) to provide both HRMS and high-resolution, accurate-mass (HRAM) as well as inductively coupled plasma mass spectrometry (ICP-MS), which enable coverage of a broad scope of impurities ranging from volatile to non-volatile organic compounds. 

The company notes several new regulatory requirements for drug products, including the finalization earlier in 2017 of ICH M7, Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk, a guideline by the International Conference of Harmonization (ICH) that provides a practical framework applicable to the identification, categorization, qualification, and control of mutagenic impurities to limit potential carcinogenic risk, and the upcoming required compliance of USP <232> and USP <233> by January 1, 2018, which provides direction related to elemental-impurities-limits and procedures that align requirements mostly with ICH Q3D, Guideline for Elemental Impurities.

Source: AMRI