Papers of special note have been highlighted as: • of interest
References
- 1. . Metabolites in safety testing. Bioanalysis 1, 1193–1200 (2009).
- 2. . Guidance for Industry: Bioanalytical Method Validation. MD, USA (2018).
- 3. . Guidance on Bioanalytical Method Validation. London, UK (2011).
- 4. . ICH harmonized guideline: bioanalytical method validation and study sample analysis, M10 (2022). • Summarizes the bioanalytical method validation guidance published by various regulatory agencies and related articles on presence of impurities in standards.
- 5. . USP chapters <1086> impurities in drug substances and drug products. In:USP 41. US Pharmacopeial Convention, MD, USA (2018).
- 6. . ICH harmonized triplicate guideline: impurities in new drug substances, Q3A (R2) (2006).
- 7. . Guidance for Industry, ANDAs: Impurities in Drug Substances. MD, USA (2009).