Complete Service for Preparation Quality Research

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Service Introduction

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)

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