1. ICH Q6A 1999 Specifications: Test procedures and acceptance criteria for new drug substances and new drug products: Chemical substances
2. ICH Q8(R2) 2009 Pharmaceutical development
3. ICH M7 2014 Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk
4. ICH Q2(R1) Validation of analytical procedures: Text and methodology
5. ICH M3(R2) 2009 Guidance on nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals