【正文】 關系來評估。Accuracy is calculated as the percentage of recovery by the assay of the known added amount of analyte in the sample, or as the difference between the mean and the accepted true value, together with confidence intervals.The ICH documents remend that accuracy should be assessed using a minimum of nine determinations over a minimum of three concentration levels, covering the specified range (., three concentrations and three replicates of each concentration).準確度通過對樣品中已知加入量的分析物的含量測定的回收率來計算，或以平均值和可接受值的差值，以及置信區(qū)間來計算。在不可以獲得某些雜質或降解產物的樣品情況下，結果可以和獨立的方法獲得的結果比較。In the case of quantitative analysis of impurities, accuracy should be assessed on samples (of drug substance or drug product) spiked with known amounts of impurities. Where it is not possible to obtain samples of certain impurities or degradation products, results should be pared with those obtained by an independent procedure. In the absence of other information, it may be necessary to calculate the amount of an impurity based on parison of its response to that of the drug substance。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.如果對某一劑型的產品的含量測定，準確度可以通過采用分析方法對加入已知量的分析物（在方法的范圍內）的制劑組分的合成混合物進行測定。在ISO中，準確性的概念融合了不偏性（術語來講“真實性”和精確性）。關于術語的注釋:1225的準確性的定義和ICHQ2符合于不偏性。precision.]定義分析方法的準確度是采用分析方法獲得的檢測結果和真實值之間的接近程度?！皌rueness”)unbiasednessconceptsbinesISO,meaning.a“accuracy”StandardizationOrganizationthedocuments(VIM)ofInternationalInunbiasednesscorrespondsICH?1225?accuracydefinitionterminology:note對于這些方法，使用者可以參考單獨藥典章節(jié)，這些章節(jié)敘述的是特定的分析驗證特性和特定的驗證。藥典里的方法驗證可能會用一些或者全部的在表1和表2中列出的典型分析特性。specificandvalidationthosechapterreferred to the individualuserthesesuggested in Chapterprinciples of validation may extend beyondthe2. For some pendialinanalyticaltypecategorizedTableoutlinedvalidationincharacteristicsof the suggested typicalorpendialvalidationanalyticalofwidevalidateis appropriateinformationtoisChapter changes in the position of the drug product。 or the use of an established general procedure with a new product or raw material (see below inof procedures. 當獲得代表性樣品用于驗證程序時，應考慮處理條件和材料隔離的影響。obtaining a representative sampleconsideredshouldofforandprocessingeffects然而,用于方法驗證中的典型的分析可以應用于使用來源于化學計量模型的那些方法。測試結果也可以是，但不需要是，最終的，可報告的值，此值可用于比較一個規(guī)范的接受標準。因此，一個測試結果可以是由幾個測定值計算出來的結果。 測試方法應該指定一個或多個單獨的度量，以及它們的平均值，或者其他適當?shù)暮瘮?shù)(如中值或標準差)，作為測試結果。“分析過程的描述應該定義這個過程的測試結果。chemometricofthetobevalidationinanalytical characteristicsthemodels.maypropertyacceptance criteria of a specification. Validationpare towouldvalueneed not be, the final, be,alsotestitself.”the observedsimplevalues. Inseveralcalculatedresultaandstandardcorrection of gas volumesapplied, suchtostandardresult.It may alsothereportedthe standardmedianasappropriatemade, and their average,orindividual measurementsnumberonespecifytest method. The test methodacarryingobtainedvalue of ai