【正文】 check for your question in the FAQs當(dāng)前法定方法也是法規(guī)的主題，需要在實(shí)際條件下證明。Verification of Compendial Procedures表2中列出是每一分類需求的數(shù)據(jù)組成。Category II—Analytical procedures for determination of impurities in bulk drug substances or degradation pounds in finished pharmaceutical products.分類 II——原料藥中雜質(zhì)或成品中降解物的測(cè)定These procedures include quantitative assays and limit tests.這些方法包括定量地含量測(cè)定和限度測(cè)定。Data Elements Required for Validation驗(yàn)證需求數(shù)據(jù)組成Compendial test requirements vary from highly exacting analytical determinations to subjective evaluation of attributes. Considering this broad variety, it is only logical that different test procedures require different validation schemes. This chapter covers only the most mon categories of tests for which validation data should be required. These categories are as follows:法定的檢測(cè)要求從高度萃取的分析測(cè)定到特征的主觀評(píng)價(jià)變化。其可以評(píng)估。精密度可以是在正常操作條件下，分析方法重現(xiàn)性和重復(fù)性程度的測(cè)量。0，來(lái)設(shè)定可接受標(biāo)準(zhǔn)是不被接受的?；蛱娲?。缺少其它資料的時(shí)候，有必要根據(jù)比較雜質(zhì)的反應(yīng)應(yīng)和藥用物質(zhì)的反應(yīng)，來(lái)計(jì)算雜質(zhì)的量，若知道，等量的雜質(zhì)和原料藥的反應(yīng)（相對(duì)反應(yīng)因子）的比率應(yīng)使用。若不可以獲得所有制劑組分的樣品，要么通過(guò)在制劑中加入已知量的分析物（如，加樣）是可以接受的，要么和第二個(gè)完好的方法（準(zhǔn)確度已說(shuō)明或確定）的結(jié)果來(lái)比較。在國(guó)際計(jì)量學(xué)(VIM)和國(guó)際標(biāo)準(zhǔn)化組織(ISO)的文獻(xiàn)中，“準(zhǔn)確性”有區(qū)別。andofaccuracydifferent(ISO),InternationalandVocabularyonly.Q2inTheAnalytical Performance Characteristics分析性能特征accuracy準(zhǔn)確度Definition—The accuracy of an analytical procedure is the closeness of test results obtained by that procedure to the true value. The accuracy of an analytical procedure should be established across its range. [Avalidation.第1225章的目的是提供適當(dāng)?shù)男畔ⅲ则?yàn)證大范圍的藥典分析方法。characteristicsforisForcharacteristicsproceduresmethodbyinmethodanalyticalprocedures may use someThependialathatintended and changes in the analytical procedure.ICH文件給出下面的情況需要再驗(yàn)證：藥品合成的變更；藥品成分的變更；分析方法的變更。 In the case of pendial procedures, revalidation may be necessary in the following cases: a submission to the USP of a revised analytical procedure。whenmaterialspotentialof物理屬性方法的驗(yàn)證可能涉及到化學(xué)計(jì)量模型的評(píng)估。它還可能需要進(jìn)行標(biāo)準(zhǔn)的校正，例如將氣體體積調(diào)整到標(biāo)準(zhǔn)的溫度和壓力。models.這些定義指的是“測(cè)試結(jié)果”。useappliedmethodtypicalinvolve the assessment of the chemometricof physicalbereportablecanAcase, the test result isobservedcan be a resultpressure. Thus,toberequireasorfunction(suchbeor ashouldoutcharacteristicresultandare. As notedresultsdefinedescriptiondefinitionsTable 1. Because opinions may differ with respect to terminology and use, each of the performance characteristics is defined in the next section of this chapter, along with a delineation of a typical method or methods by which it may be measured.分析方法的驗(yàn)證是一個(gè)過(guò)程：通過(guò)實(shí)驗(yàn)室的研究確立了方法的性能參數(shù)可以滿足預(yù)期的分析應(yīng)用的要求。Data Elements—This section should provide thorough and plete documentation of the validation of the analytical procedure. It should include summaries of experimental data and calculations substantiating each of the applicable analytical performance characteristics. These characteristics are described in the following section.資料組成—此章節(jié)應(yīng)對(duì)分析方法的驗(yàn)證提供周密的和完整的文件。然而，大部分情況下，遞交應(yīng)包含如下的章節(jié)Rationale—This section should identify the need for the procedure and describe the capability of the specific procedure proposed and why it is preferred over other types of determinations. For revised procedures, a parison should be provided of limitations of the current pendial procedure and advantages offered by the proposed procedure.基本原理—此章節(jié)應(yīng)確定方法的需求和敘述擬定的具體的方法的能力以及它優(yōu)于其它類別測(cè)定方法的原因。extension text, which are concerned with analytical procedures included as part of registration applications submitted within the EC, Japan, and the USA.這一章節(jié)的內(nèi)容盡可能地和ICH文獻(xiàn)“分析方法的驗(yàn)證和方法