Assessment and Testing Service for Elemental Impurities
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The Titanium Chemical, Manufacturing and Control (CMC) team is familiar with various ICH Q3D and NMPA regulations and guidelines, owns rich experience in quality study, can provide a study on element impurities on various dosage forms of innovative chemical drugs and generic drugs, and can fully support customers' quality study demands for APIs and preparation. At present, nearly 70 kinds of element impurity methods have been studied.
Assessment strategy for element impurity control
Method development, verification and testing of elemental impurities in APIs, excipients and preparation products
