1. International Conference on Harmonisation (ICH).Guideline Q3A (R2): Impurities in New Drug Substances; October 2006.
2. International Conference on Harmonisation (ICH).Guideline Q3B (R2): Impurities in New Drug Products; 2006.
3. International Conference on Harmonisation (ICH).Guideline Q3C (R4): Impurities: Guidelines for Residual Solvents; 2009.
4. International Conference on Harmonisation (ICH). M7 Tripartite Guideline.Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk, Current Step 4 version; 23 June 2014.
5. Impurity Occurrence and Removal in Crystalline Products from Process Reactions