内容提示: Verification 确认 。 针对使用法定方法(注意: 需要严格遵守方法要求 参数, 试剂, 标准品, 步骤等等), 需要在目前实验室的条件下确认是否可以获得可靠结果. 不一定是全部项目的验证 FDA 针对常州 SPL 肝素钠的警告信中就有关于方法确认的内容. 可以参考。 <1226> VERIFICATION OF COMPENDIAL PROCEDURES ...
882〈1226〉 Verification of Compendial Procedures / General Information USP 35 terial to which the procedure is applied. Although complete 〈1226〉 VERIFICATION OF revalidation of a compendial method is not required to ver-ify the suitability of v a procedure v USP35 under actual condi-...
药典规程的确认--美国药典usp1226(中英对照) 热度: 相关推荐 Verification:确认。针对使用法定方法(注意:需要严格遵守方法要求,参数,试剂,标准品,步骤等等),需 要在目前实验室的条件下确认是否可以获得可靠结果.不一定是全部项目的验证,FDA针对常州SPL肝素 钠的警告信中就有关于方法确认的内容.可以参考。 <1226>...
USP401226药典的确认中英文对照.pdf,. 1226 VERIFICATION OF COMPENDIAL PROCEDURES 药典方法的确认 The intent of this general information chapter is to provide general information on the verification of compendial procedures that are being performed for the f
1226VERIFICATIONOFCOMPENDIALPROCEDURES 药典方法的确认 Theintentofthisgeneralinformationchapteristoprovidegeneral informationontheverificationofcompendialproceduresthatarebeing performedforthefirsttimetoyieldacceptableresultsutilizingthepersonnel, equipment,andreagentsavailable. ...
1、1226 VERIFICATION OF COMPENDIAL PROCEDURES药典方法的确认The intent of this general information chapter is to provide general information on the verification of compendial procedures that are being performed for the first time to yield acceptable results utilizing the personnel, equipment, and reagents ...
Other analytical performance characteristics such as an assessment of the limit of detection or quantitation and precision for impurities procedures may be useful to demonstrate the suitability of the compendial method under actual conditions of use. Verification is not required for basic compendial test ...
USP 通则 61 62 71 1225 1226教程文件.doc,1225VALIDATION OF COMPENDIAL PROCEDURES 药典规程的验证 Test procedures for assessment of the quality levels of pharmaceutical articles are subject to various requirements. According to Section 501 of the Federal F
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,而不是重复验证的过程。
PENDIALPROCEDURES药典方法确实定 eptableresultsutilizingthepersonnel,equipment,,使用人员,设备和试剂使第一次进行利用药典方法以产生可接收结果。 pendialProcedures<1225>panyanalyticalproceduressubmittedforinclusionin USP–NF. Verificationconsistsofassessingselectedanalyticalperformancecharacteristics,suchasthosethataredescribe...