AMRI: stand-alone analytical testing services launched ahead of regulatory changes

By Melissa Fassbender contact

- Last updated on GMT

(Image: Getty/JK1991)
(Image: Getty/JK1991)
AMRI is offering its impurity solutions as a stand-alone service in response to new regulatory requirements that set limits for the amounts of elemental impurities in drug products.

Several trends in analytical testing follow new regulatory requirements, including the implementation of the International Council for Harmonization’s (ICH) Q3D Elemental Impurities guideline​, and more recently, ICH M7​ – the purpose of which is "to provide a practical framework that is applicable to the identification, categorization, qualification, and control of [mutagenic impurities] to limit potential carcinogenic risk,​" according to the guideline.

Additionally, the United States Pharmacopeial Convention’s (USP’s) requirements for controlling elemental impurities set out in USP <232> and USP <233>​ provide analytical methods and validation criteria that will be enforced beginning January 1, 2018.

In response to these regulatory changes, AMRI is offering its impurity solutions as a stand-alone service, which “opens up opportunities for other prospective customers, extending to them our years of impurity-focused process knowledge for chemical compounds,” ​said John Iannone, director, extractables/leachables and impurities.

This will more thoroughly and accurately help them understand impurity control requirements from a toxicological perspective to ensure the safety and efficacy of our customers’ products and improve drug development efforts​,” Iannone told Outsourcing-Pharma.com.

The contract research, development and manufacturing organization's (CDMO) analytical services include a range of solutions, which Iannone said are designed to satisfy various industry and regulatory requirements.

Through the years, AMRI has gained a wealth of knowledge and expertise working on a variety of projects as a CRO/CDMO​,” he added.

As a result of working with so many different kinds of customers and projects/products, we have the ability to leverage an extraordinary and diverse database of mass spectral data and methods for analyzing extractables/leachables and impurities, which enables us to better detect and measure these trace compounds​.” 

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