Complete Service for Preparation Quality Research
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The Titanium Chemical, Manufacturing and Control (CMC) team is familiar with various ICH and NMPA regulations and guidelines, owns rich experience in quality study, can provide overall quality study and stability study on various dosage forms of innovative chemical drugs and generic drugs, and can fully support customers' quality study demands for APIs and preparation.
Study on consistency evaluation of generic drugs
Content and related substance method development and verification
Study on compatibility of raw materials
In vitro evaluation (dissolution method development, validation and similarity evaluation)
Establishment of quality standard
Stability study (influencing factor test, accelerated test, long-term test, intermediate condition test)
