Complete Service for API Quality Research
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The Titanium Chemical, Manufacturing and Control (CMC) team is familiar with various ICH and NMPA regulations and guidelines, and owns rich experience in quality study. It can provide overall quality study and stability study for chemical drugs, and can fully support customers' quality study needs for APIs.
Study on consistency evaluation of generic drugs
Study on screening of new drug compounds
Study on content of starting materials and intermediates, APIs, related substances, residual solvents and elemental impurities
Confirmation of compound structure
Method development and validation
Establishment of quality standard
Stability study (influencing factor test, accelerated test, long-term test, intermediate condition test)
