The Technical Guidelines for the Study of Impurities in Chemical Pharmaceuticals was issued on Mar. 18, 2005. It gives technical guidelines for the study of impurities in chemical pharmaceuticals in China, which includes:

1. Overview

2. Classification of Impurities

3. Analytical Method

4. Accumulation of Impurity Detection Data

5. Establishment of Impurity Limits

6. Impurity Research at Clinical Research Application and Marketing Production Application Stages

7. Conclusion

8. Glossary

9. Appendix

10. References