Chapter??1225??is?intended?to?provide?information?that?is appropriate?to?validate?a?wide?range?of?compendial?analytical?procedures.??The?validation?of?compendial?procedures may use some?or?all?of the suggested typical?analytical?characteristics?used?in?method?validation?as?outlined?in?Table?1and?
Procedures: Method Development,Procedure Performance Qualification, and Procedure PerformanceVerification" ...
Chapter1225isintendedtoprovideinformationthatis appropriatetovalidateawiderangeofcompendialanalyt 25、icalprocedures.Thevalidationofcompendialprocedures may use someorallof the suggested typicalanalyticalcharacteristicsusedinmethodvalidationasoutlinedinTable1andcategorizedbytypeofanalyticalmethodinTable2. For some ...
FDA:方法验证是一个阐述分析方法适合于其使用目的的过程。 02方法确认(Verification of method) USP<1225>:USP-NF所收载方法的使用者不需要验证这些方法的准确性和可靠性,但需要确认这些方法在实际使用条件下的适应性。 USP<1226>:确认包括所涉及方法的性能参数,如那些在<1225>中描述的,以建立恰当的、相应的数据,...
compendial method is not required to verify the suitability of the method under actual conditions of use, some of the analytical performance characteristics listed in chapter <1225>, Table 2, may be used for the verification process. Only those characteristics that are considered to be appropriate ...
Although complete revalidation of a compendial method is not required to verify the suitability of the method under actual conditions of use, some of the analytical performance characteristics listed in chapter <1225>, Table 2, may be used for the verification process. Only those characteristics ...
USP scientists cannot review and interpret data, per the OfficialStatements and Interpretations policy: “USP shall not provide an officialopinion as to whether a particular article does or does not comply withcompendial requirements, except as part of an esta...
–Contactprocesschemistsforspecificrequirements –DOE •MethodOptimization(ChemistryandGame) •MethodValidation(ChemistryandExpertise) –Identifypurposeofthemethod –Determineparameterstovalidate –Developvalidationprotocol –Generatedataandreport •MethodTransferand/orMethodVerification(ChemistryandWork) USPMonograph...
Although complete revalidation of a compendial method is not to verify the suitability of a procedure under actual conditions some of the analytical performance characteristics listed inrequiredof use,chapter1225,Table 2,m 14、ay be used fortheverificationprocess.尽管在实际使用条件下, 不要求对药典方法...
1225,?Table 2,?may be used for the verification process. 在1226中列出的分析性能参数〔表格2〕,可用于确认的过程。 Only those characteristics that are considered to be appropriate for the verification of the particular method need to be evaluated. The process of accessing the suitability of a ...