1. ICH Q3 Q3A(R): Impurities in New Drug Substances (Revised Guideline);Fed. Regist.,2003
2. Q3B(R): Impurities in New Drug Products (Revised Guideline);Fed. Regist.,2003
3. Q3C: Impurities: Guideline for Residual Solvents;Fed. Regist.,2003
4. European Medicines Evaluation Agency, Committee for Medicinal Products for Human Use (CHMP), Guideline on the limits of genotoxic impurities, CPMP/SWP/5199/02, London, UK, 23 June 2004.
5. Use of Genotoxicity Data to Support Clinical Trials or Positive Genetox Findings on a Candidate Pharmaceutical or Impurity …. Now What?