The US Pharmacopeia (USP) retired the existing wet chemistry heavy metals methods outlined in USP General Chapter <231> with an instrument-based approach on January 1, 2018. Though the existing wet chemistry methods have been in effect for nearly 100 years, the methods were non-specific and frequently failed to detect or underestimate the presence of some toxic elements that are potentially present in pharmaceutical ingredients.
Throughout this guidebook, Alcami scientists will discuss heavy metal regulations, moving to a risk-based approach, the role of risk assessment in the manufacturing process, goals and accountability, and agency-accepted testing and filing strategy for elemental impurities.
2 min read
Alcami : Feb 8, 2017 11:00:00 AM
The U.S. Pharmacopeia (USP) intends to remove the existing wet chemistry heavy metals methods outlined in USP General Chapter <231> by January 2018....
8 min read
Alcami : Apr 15, 2019 3:00:00 PM
1 min read
Alcami : Jan 24, 2017 9:00:00 AM
In 2013, the International Conference on Harmonization (ICH) approved ICH Q3D, a Guideline for Elemental Impurities, which replaced wet chemistry...
Alcami