Perform Compliant USP 232 and ICH Q3D Elemental Analysis
Application Note Dec 15, 2019
Elemental impurities in pharmaceutical formulations can interfere with drug efficacy or have a toxic effect on the patient. Regulators have issued guidelines—such as ICH Q3D, USP 232 and USP 233 Elemental Impurities.
Download this application compendium to learn how to monitor a range of metal elemental impurities in pharmaceutical materials using elemental analysis techniques such as:
- ICP-MS or,
As well as tips to ensure specific validation requirements described in the guidelines are met.