1. General Requirements for the Competence of Testing and Calibration Laboratories;ISO/IEC 17025,2005
2. United States Pharmacopeia and the National Formulary (USP 25-NF 20), United States Pharmacopeial Convention, Rockville, MD, 2002.
3. International Conference on Harmonization, Draft Guidance on Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and Products: Chemical Substances, Federal Register (Notices) 65 (2000) 83041.
4. FDA, Analytical Procedures and Methods Validation: Chemistry, Manufacturing, and Controls, Federal Register (Notices), 65 (2000) 52776.
5. Is it really necessary to validate an analytical method or not? That is the question