【正文】 mance characteristics (., dissolution, drug release).分類 III——用于測(cè)量性能特征的分析方法（如，溶出度，藥品釋放）Category IV—Identification tests.分類IV——鑒別試驗(yàn)For each category, different analytical information is needed. Listed inTable 2. Data Elements Required for Validation表2 驗(yàn)證需求的資料組成AnalyticalPerformanceCharacteristics分析性能參數(shù)Category I分類ICategory II分類IICategory III分類IIICategory IV分類IVQuantitative定量LimitTests限度Accuracy準(zhǔn)確度Yes是Yes是**No否Precision精密度Yes是Yes是No否Yes是No否Specificity專屬性Yes是Yes是Yes是*Yes是Detection LimitNoNoYes*NoQuantitation Limit定量限No否Yes是No否*No否Linearity限度Yes是Yes是No否*No否Range范圍Yes是Yes是**No否l1226見1226。before contacting USP.輔助信息——在聯(lián)系USP前請(qǐng)核對(duì)FAQ中你們的問題Topic/Question話題/問題Contact聯(lián)系Expert Committee專家委員會(huì)General Chapter總章節(jié)Horacio N. Pappa, .Senior Scientist and Latin American Liaison13018168319(GC05) General Chapters 05USP32–NF27Auxiliary Information— Please因此，成功完成這些研究的文件是確定方法是否適用的基本要求。 取決于特定檢測(cè)的性質(zhì)，可能需要Already established general procedures (., titrimetric determination of water, bacterial endotoxins) should be verified to establish their suitability for use, such as their accuracy (and absence of possible interference) when used for a new product or raw material.對(duì)已經(jīng)建立的總的方法（如，水分的滴定測(cè)定，細(xì)菌內(nèi)毒素）證明以建立其系統(tǒng)適應(yīng)性，如其準(zhǔn)確度（適當(dāng)干預(yù)的存在），當(dāng)用于新產(chǎn)品或原輔料The validity of an analytical procedure can be verified only by laboratory studies. Therefore, documentation of the successful pletion of such studies is a basic requirement for determining whether a procedure is suitable for its intended application(s). Current pendial procedures are also subject to regulations that require demonstration of suitability under actual conditions of use (seeare data elements that are normally required for each of these categories.對(duì)于每一分類，需要不同的分析資料資料。這些分類如下：Category I—Analytical procedures for quantitation of major ponents of bulk drug substances or active ingredients (including preservatives) in finished pharmaceutical products.分類 I——成品中原料藥的主要組分或活性組分的定量測(cè)定的分析方法。USP的遞交應(yīng)注意系統(tǒng)適應(yīng)性的要求，色譜法621621.系統(tǒng)適應(yīng)性檢測(cè)是基于設(shè)備，電子，分析操作，和待分析樣品組成了完整的系統(tǒng)。重復(fù)性指的是在同一實(shí)驗(yàn)室內(nèi)，一小段時(shí)間內(nèi)，由同一實(shí)驗(yàn)人員在相同的設(shè)備上進(jìn)行分析。分析方法的精密度通常以一系列測(cè)量值的標(biāo)準(zhǔn)偏差或相對(duì)標(biāo)準(zhǔn)偏差（變異系數(shù)）來表示。基于缺少統(tǒng)計(jì)學(xué)意義的檢測(cè)，假定斜率等于1。Assessment of accuracy can be acplished in a variety of ways, including evaluating the recovery of the analyte (percent recovery) across the range of the assay, or evaluating the linearity of the relationship between estimated and actual concentrations. The statistically preferred criterion is that the confidence interval for the slope be contained in an interval around , or alternatively, that the slope be close to . In either case, the interval or the definition of closeness should be specified in the validation protocol. The acceptance criterion will depend on the assay and its variability and on the product. Setting an acceptance criterion based on the lack of statistical significance of the test of the null hypothesis that the slope 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。在不可以獲得某些雜質(zhì)或降解產(chǎn)物的樣品情況下，結(jié)果可以和獨(dú)立的方法獲得的結(jié)果比較。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 ran