tailieunhanh - Introduction to Modern Liquid Chromatography, Third Edition part 60

Introduction to Modern Liquid Chromatography, Third Edition part 60. 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. . | 546 METHOD VALIDATION an introduction or objective method summary including instrument and solution preparation specifics validation results in subsections organrzed by the characteristic studied. Each subsection should include a brief summary of the applicable protocol and the mean standard deviation relative standard deviation acceptance criteria and assessment pass orfail . any deviations bom c pr seouol plisnncdos olsseraed and theimpact if any onthovalidasion any amendmentsOotheproSocol wiehooptanations anvaparovolt conclusion A properly desired voOdatsonpretocoScansasaeas a temolatefartheoolidstloo report. For exampie Sn Sic noodvcola test can be described and the acceptance entena listed. Oov nhvaodtOandn mformvnod issaadlemonlad adlh supporting results a reference to the location and identity of the raw data and a pass fail statemone. VAUDAHONFOR Dll iadN pharmaceuticac-mcthodd oypvs The USP recognizes that is it not always necessary to evaluate every analytical performance characteristic for every test method. The type of method and its intended usedictatewhichperformancecharacteristicsneed to be investigated as summarized in Table 12 .Both theUSP and UCHdivide test methods into four separate categories assayo for thequantifisvtion os majorromponentt nr active mgredionns causrasal eio evvsl detccminetido of Srnpuriries or degratakor ptmlnio cams 2 mechons deteammntioo oapooduct performance characteristics category 3 methods ldentlficatiootestr cateuord4mee0oas These test niethodsaocl narcaosnagciicrally apply to drug substances and drug products as opoosudsabSoaanSysicaldcmplrSseoveredln . CategoiyiMeShoa0 l co Category 1 tests target the analysis of major components and include test methods such as content umform and ster mctliods while qricotitasior are not uduallyconorraad wish lowos l asotaladysc butontywiththe amount oUehcAFl Crrhedrug of rhe simplicity of rhe .