Technical Guidelines for Quality Control Research of Chiral Pharmaceuticals
Request Technical Guidelines for Quality Control Research of Chiral Pharmaceuticals
  • Local Title:手性药物质量控制研究技术指导原则
  • Country/Region:Chinese Mainland
  • Competent Authority: Former China Food and Drug Administration (CFDA)
  • Type:Guideline
  • Status:In force
  • Release Date:2006-12-19
  • Implementation Date:2006-12-19
Document
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ZH Official 手性药物质量控制研究技术指导原则 Download
Summary

The Technical Guidelines for Quality Control Research of Chiral Pharmaceuticals was issued on Dec.19, 2006. It gives the technical guidelines for quality control research of chiral pharmaceuticals in China, which includes:

I. Overview

2. Basic Approach to Chiral Drug Pharmaceutical Research

3. Synthesis of Active Pharmaceutical Ingredients

4. Structure Confirmation

5. Preparation Prescription and Process

6. Quality Research and Quality Standards

7. Stability Research

8. Explanation of Terms

9. References