1. ICH Q3A (R2); Impurities new drug substances, International Conference on Harmonization Tripartite Guideline, (2006).
2. ICH Q3B (R2); Impurities in new drug products, International Conference on Harmonization Tripartite Guideline, (2006).
3. European Medicines Agency; Guideline on the limits of genotoxic impurities, CPMP/SWP/5199/02, EMEA/CHMP/QWP/251344/2006, (2007).
4. ICH M7; Assessment and control of DNA reactive (Mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk. International Conference on Harmonisation of Technical Requirements For Registration of Pharmaceuticals for Human use, Step 2, (2013).
5. Ultra high performance liquid chromatography coupled with high resolution quantitation mass spectrometry method development and validation for determining genotoxic 2,5-dichlorobenzoyl chloride in MLN9708 drug substance;Fu;Journal of Pharmaceutical and Biomedical Analysis,2014