Posts about
Elemental Impurities
eBook: Elemental Impurities
The US Pharmacopeia (USP) retired the existing wet chemistry heavy metals methods outlined in USP...
Blog: Agency-Accepted Testing and Filing Strategy for Elemental Impurities
The new elemental impurities regulations stress the importance of controlling all sources of ...
Elemental Impurities: The Risk-Based Approach
The U.S. Pharmacopeia (USP) intends to remove the existing wet chemistry heavy metals methods...
Elemental Impurities: Updated Regulatory Requirements
In 2013, the International Conference on Harmonization (ICH) approved ICH Q3D, a Guideline for...