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Introduction to Modern Liquid Chromatography, Third Edition part 61

Introduction to Modern Liquid Chromatography, Third Edition part 61. High-performance liquid chromatography (HPLC) is today the leading technique for chemical analysis and related applications, with an ability to separate, analyze, and/or purify virtually any sample. Snyder and Kirkland's Introduction to Modern Liquid Chromatography has long represented the premier reference to HPLC. This Third Edition, with John Dolan as added coauthor, addresses important improvements in columns and equipment, as well as major advances in our understanding of HPLC separation, our ability to solve problems that were troublesome in the past, and the application of HPLC for new kinds of samples. . | 556 METHOD VALIDATION that involve additional manufacturing sites and or contract laboratories. In general comparative testing is most often used for late-stage methods and for the transfer of more complex methods. 12.7.1.2 Co-validation between Laboratories Comparative testing Sectionl2.7.1.1 traditionally requiresa validated method as a prerequisileto AMT.Howeuer anather o ion forAMT iseo incoke vhe receiving lilsdnatui nomlhvbeginning in the actual validation of the test method to be transferred. By completing a co-validation study the receiving laboratory is coiisideredqualiHcdtopcrforrn thetest methodfor release testing. To perform this transCemptie ntthe rrceivinn laUaratorymustbe tnavlvedin tdnntifyingthn intermediate vrpclninn volldationcharacteristicstoaervniueied anOshe experimrnttt design. Byindgsionotdataeeornii Ivhoratorittinaolvddinihe stuC. isis oosvlbln to have ths validationreporteeeu7 asproof of MIT rt h aor u equininn n ssuaratt validation studcbdehereceivmg laboos . 12.7.1.3 SOr ih id alhlptHtg ariOtaiCavislidaiioa Another teehniquethatcanbe used fosAMT mvvket rhet-sctkin0 Iabo1aeotyls repeating somcorall ogths oridinatmd taboraios s valxlaaioii rvu1rimeatt.As with 00 31 1 56 1100 .7.1.2d b.aomjsletm art of a validation study the receivind laboratory is considered qualified to perform routine release testing. With this process the labosatoryotadOand o mlity ouit dooermine how much testing is required tntugshd AMT. 12.7.1.4 TravstufWa car A transfee tdtgtti la ueevw0eo ufoeThl AMT h nutnoeit77 re.g. compehdlal methods v.td fos domr dthet thuatiom tliatniaywerrai.r cmlt7iouofa fomaal edn1ted c rs oartooe nxar thsrecsivinglodoratorounrrently tests the product with another method a test merfiod oo in use far e dosage 0 700 3 16 10 6 newproduct th7eessmrthod oeone7eryrimilarlitaireodym usefooahotUer amplication thexcw merhodinvolveshhoauestCatCo not significantly alter the use of an existing 16810 1 the personnrlac7ompanythe rrmo er oCAe teosm7ttn .