EAG opens elemental impurities lab citing US FDA alignment efforts
The lab - located at EAG’s facility in Columbia, Missouri - houses six inductively coupled plasma/mass spectrometry instruments, which will be used to test drug ingredients and excipients for metal impurities.
The firm cited recommendations published by the US Food and Drug Administration (FDA) in June in which the agency outlined its efforts to align testing rules with International Council for Harmonisation (ICH) guidance and United States Pharmacopeia (USP) requirements.
The regulations – which come into effect in January 2018 – require that manufacturers of brand-name, generic and over-the-counter drugs
Elemental impurities are traces of metals that present in drug formulations as a result of the production process. The impurities can be harmful to patients, which is why regulators require that that drug firms measure and control for their presence.
EAG did not respond to a request for comment.
Combination
EAG recently combined 11 of its brands, including ABC Laboratories, to reside under a single company.
As this publication previously reported, the company has been expanding it capabilities to further support the biopharmaceutical market.
Siddhartha Kadia, EAG Laboratories president and CEO told us the life science market is a “key growth engine” for the company and that it will continue to invest, both organically and additively, in areas that complement the company’s offerings.
