1. “Impurities in New Drug Substances”, Q3A(R2);International Conference on Harmonisation,2006
2. “Impurities in New Drug Products”, Q3B(R2);International Conference on Harmonisation,2006
3. Guideline on the Limits of Genotoxic Impurities (CHMP),2006
4. A rationale for determining, testing, and controlling specific impurities in pharmaceuticals that possess potential for genotoxicity
5. Genotoxic and Carcinogenic Impurities in Drug Substances and Products. Recommended Approaches (Draft);FDA Guidance for Industry,2008