1. International Conference on Harmonization; Guidance on Q6A specifications: test procedures and acceptance criteria for new drug substances and new drug products: chemical substances;FDA;Fed Regist,2000
2. FDA. Guidance for Industry INDs for Phase 2 and Phase 3 Studies Chemistry, Manufacturing, and Controls Information. Available from: www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/; May 2003.
3. FDA. Guidance for Industry Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients. Available from: www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/; August 2001.
4. FDA. Guidance for Industry, Q11 Development and Manufacture of Drug Substances, ICH; November 2012.
5. FDA. Guidance for Industry, Q8(R2) Pharmaceutical Development, ICH; November 2009.