【正文】 is is not an acceptable approach.準(zhǔn)確度的評(píng)估可以通過多種不同的方式來完成，包括評(píng)估在含量范圍內(nèi)的分析物的回收率，或被估測(cè)的和實(shí)際濃度見的線性關(guān)系來評(píng)估。In the case of the assay of a drug in a formulated product, accuracy may be determined by application of the analytical procedure to synthetic mixtures of the drug product ponents to which known amounts of analyte have been added within the range of the procedure. If it is not possible to obtain samples of all drug product ponents, it may be acceptable either to add known quantities of the analyte to the drug product (., “to spike”) or to pare results with those of a second, wellcharacterized procedure, the accuracy of which has been stated or defined.如果對(duì)某一劑型的產(chǎn)品的含量測(cè)定，準(zhǔn)確度可以通過采用分析方法對(duì)加入已知量的分析物（在方法的范圍內(nèi)）的制劑組分的合成混合物進(jìn)行測(cè)定。“trueness”)ISO,Standardization(VIM)unbiasednessaccuracy對(duì)于這些方法，使用者可以參考單獨(dú)藥典章節(jié)，這些章節(jié)敘述的是特定的分析驗(yàn)證特性和特定的驗(yàn)證。validationuserprinciples of validation may extend beyondanalyticaloutlinedof the suggested typicalvalidateisof procedures. 當(dāng)獲得代表性樣品用于驗(yàn)證程序時(shí)，應(yīng)考慮處理?xiàng)l件和材料隔離的影響。ofeffects 測(cè)試方法應(yīng)該指定一個(gè)或多個(gè)單獨(dú)的度量，以及它們的平均值，或者其他適當(dāng)?shù)暮瘮?shù)(如中值或標(biāo)準(zhǔn)差)，作為測(cè)試結(jié)果。theinmaywouldalsosimpleresultcorrection of gas volumesresult.It may alsomedianindividual measurementstest method. The test methodvalue of a57251testTheVALIDATION驗(yàn)證Validation of an analytical procedure is the process by which it is established, by laboratory studies, that the performance characteristics of the procedure meet the requirements for the intended analytical applications. Typical analytical performance characteristics that should be considered in the validation of the types of procedures described in this document are listed in涉及方法的類別改變，資料可能也會(huì)改變?？紤]到USP和NF的法律地位，采用新的或修改后的藥典分析方法的建議，并且這個(gè)建議是由充分的實(shí)驗(yàn)室數(shù)據(jù)支持以證明其有效，這是十分必要的。USP–NFNFand theProposed Analytical Procedure—This section should contain a plete description of the analytical procedure sufficiently detailed to enable persons “skilled in the art” to replicate it. The writeup should include all important operational parameters and specific instructions such as preparation of reagents, performance of system suitability tests, description of blanks used, precautions, and explicit formulas for calculation of test results.擬定的分析方法—此章節(jié)應(yīng)包含詳細(xì)完整的分析方法的敘述，使得技術(shù)人員能夠重現(xiàn)。因?yàn)閷?duì)術(shù)語和使用的觀點(diǎn)可能會(huì)有所不同，所以每個(gè)性能參數(shù)在此章節(jié)的下部分給出定義，以及典型方法或能夠測(cè)量的方法的描述。thetheabythatanotherdeviation), becorrectionstemperaturefromvaluebuttheHowever,canthe在簡(jiǎn)單的情況下，測(cè)試結(jié)果是測(cè)定值本身。conditionsbeData Elements Required for Validation).如果是藥典方法，下面的一些情況下有必要進(jìn)行再驗(yàn)證：將修改的分析方法遞交給USP；或者將擬定的關(guān)于新產(chǎn)品或原輔料總的分析方法的使用（見如下驗(yàn)證需要的資料組成）The ICH documents give guidance on the necessity for revalidation in the following circumstances: changes in the synthesis of the drug substance。providerangeofused1andTable?1225?.pendialanyonandtheofhasthe分析方法的準(zhǔn)確度應(yīng)在其范圍中建立。 the ratio of the responses of equal amounts of the impurity and the drug substance (relative response factor) should be used if known.如果是定量分析雜質(zhì)，準(zhǔn)確度可以對(duì)樣品（藥用物質(zhì)或成品藥）加入已知量的雜質(zhì)或降解產(chǎn)物來評(píng)估。認(rèn)可標(biāo)準(zhǔn)取決于含量和其變化和產(chǎn)品。中間精密度（通常也稱為粗放性）表述的是在同一實(shí)驗(yàn)室范圍內(nèi)的變化，不同的天數(shù)，不同的分析人員或相同實(shí)驗(yàn)室內(nèi)的不同儀器。對(duì)于色譜方法，至關(guān)重要的。Table 2 May be required, depending on the nature of the specific test.lfor principles relative to the verification of pendial procedures). Appropriate documentation should acpany any proposal for new or revised pendial analytical procedures.分析方法的有效性可以通過實(shí)驗(yàn)室研究來證明。Page 733Pharmacopeial Forum: Volume No. 34(3) Page 794內(nèi)容總結(jié)（1）考慮到USP和NF的法律地位，采用新的或修改后的藥典分析方法的建議，并且這個(gè)建議是由充分的實(shí)驗(yàn)室數(shù)據(jù)支持以證明其有效，這是十分必要的