【正文】 for 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驗室研究來證明。Table 2中間精密度（通常也稱為粗放性）表述的是在同一實驗室范圍內(nèi)的變化，不同的天數(shù)，不同的分析人員或相同實驗室內(nèi)的不同儀器。 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)物來評估。theofandany?1225?.1andofprovidebe在簡單的情況下，測試結(jié)果是測定值本身。canthevaluetemperaturedeviation), bethatatheProposed 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)。NF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，并且這個建議是由充分的實驗室數(shù)據(jù)支持以證明其有效，這是十分必要的。VALIDATION驗證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 intestvalue of aindividual measurementsresult.It may alsoresultalsomaytheeffectsof procedures. 當(dāng)獲得代表性樣品用于驗證程序時，應(yīng)考慮處理條件和材料隔離的影響。validateof the suggested typicalanalyticaluser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。unbiasednessStandardization“trueness”)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)確度的評估可以通過多種不同的方式來完成，包括評估在含量范圍內(nèi)的分析物的回收率，或被估測的和實際濃度見的線性關(guān)系來評估。621.系統(tǒng)適應(yīng)性檢測是基于設(shè)備，電子，分析操作，和待分析樣品組成了完整的系統(tǒng)。Auxiliary Information— Please考慮到這一廣泛的變化，不同的檢測方法要求不同的驗證項目是合理的。在ISO中，準(zhǔn)確性的概念融合了不偏性（術(shù)語來講“真實性”和精確性）。meaning.ofdefinitionthosethevalidationanalyticalChapterfor“分析過程的描述應(yīng)該定義這個過程的測試結(jié)果。analytical characteristicsvaluevalues. Inapplied, suchasainrefer to “testSUBMISSIONS TO THE COMPENDIA遞交至藥典Submissions to the pendia for new or revised analytical procedures should contain sufficient information to enable members of the USP Council of Experts and its Expert Committees to evaluate the relative merit of proposed procedures. In most cases, evaluations involve assessment of the clarity and pleteness of the description of the analytical procedures, determination of the need for the procedures, and documentation that they have been appropriately validated. Information may vary