ppt课件-methodandvalidationbasics- h p l ccasestudy（methodandvalidationbasics - h p l ccasestudy）.pptVIP

World Health Organization Outline HPLC methodology Content of HPLC test procedure System Suitability Testing (SST) - Relative Response Factor (RRF) Validation of HPLC method case study Information Sources FDA CDER reviewer guideline for validation of chromatographic methods (1994) WHO TRS 937 Appendix 4 “Analytical Method Validation 2006 ICH Q2(R1) 2005 Compendial General Chapters Methods and Validation presentation–Lynda Paleshnuik High Performance Liquid Chromatography (HPLC) HPLC is a separation technique based on a solid stationary phase and a liquid mobile phase. Separations are ac