News & Events
Elemental Impurities Analysis
Have you heard about the proposed USP <232 > and <233> guidelines for elemental impurities?
As a replacement for the current Heavy Metals procedure, <231>, this process is part of the FDA's push for the removal of non-specific methodologies that do not provide accurate, quantifiable results.
Cyanta Analytical Services has experience utilizing both microwave digestion and ICP-MS in a wide variety of matrices, including silicones, proteins, polymers, pharmaceuticals, biological samples and medical devices. We have years of experience analyzing heavy metals and other trace impurities in pharmaceutical and medical device products and have established procedures for the analysis of the class 1 and class 2 impurities as specified in the proposed USP guidelines.
Our extensive experience with microwave digestion together with ICP/MS analysis can allow your company to remain compliant with the new "heavy metals" regulation changes.
