ARE YOU READY FOR THE REPLACEMENT OF USP <231> HEAVY METALS?
Alcami Wants You to Stay in Compliance.
The U.S. 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 are non-specific and frequently fail to detect or underestimate the presence of some toxic elements that are potentially present in pharmaceutical ingredient.
The USP heavily supports Inductively Coupled Plasma Mass Spectrometry (ICP-MS) as the replacement technique to screen and/or accurately quantitate the presence of any metals of interest. USP General Chapters <232> and <233> Elemental Impurities Limits and Procedures is the expected norm for evaluation and are already accessible monographs for analysis.
- Improve testing accuracy and speed
- Initial elemental impurity assessment
- Risk assessment on current material
- Validated method for testing at release
- Risk assessment report for filing
- Standalone elemental impurity method
- Limit test
- Full quantitation analysis
- Extractables, leachables, and samples with unknown metal impurities
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Alcami has the best ICP-MS Elemental Impurity Solutions to keep you in compliance with changing compendial requirements.