【正文】 y.theVocabularyMetrologyandofInternationalfor(ISO),hasdifferentInaccuracytheof(termedand分析方法的準確度應在其范圍中建立。在國際計量學(VIM)和國際標準化組織(ISO)的文獻中，“準確性”有區(qū)別。Determination—In the case of the assay of a drug substance, accuracy may be determined by application of the analytical procedure to an analyte of known purity (., a Reference Standard) or by parison of the results of the procedure with those of a second, wellcharacterized procedure, the accuracy of which has been stated or defined.測定如果是藥品的含量測定，準確度可以通用采用分析方法對已知純度（如對照品）的測定來確定，也可以通過和使用其它的第二個完好的方法（其準確度已說明或確定）的結(jié)果比較來確定。若不可以獲得所有制劑組分的樣品，要么通過在制劑中加入已知量的分析物（如，加樣）是可以接受的，要么和第二個完好的方法（準確度已說明或確定）的結(jié)果來比較。 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。缺少其它資料的時候，有必要根據(jù)比較雜質(zhì)的反應應和藥用物質(zhì)的反應，來計算雜質(zhì)的量，若知道，等量的雜質(zhì)和原料藥的反應（相對反應因子）的比率應使用。ICH文件建議準確度通過在至少具體范圍內(nèi)，至少9次測定來評估（如，三個濃度和每個濃度的三次重復測定）?；蛱娲摹ＵJ可標準取決于含量和其變化和產(chǎn)品。0，來設定可接受標準是不被接受的。precision精密度Definition—The precision of an analytical procedure is the degree of agreement among individual test results when the procedure is applied repeatedly to multiple samplings of a homogeneous sample. The precision of an analytical procedure is usually expressed as the standard deviation or relative standard deviation (coefficient of variation) of a series of measurements. Precision may be a measure of either the degree of reproducibility or of repeatability of the analytical procedure under normal operating conditions. In this context, reproducibility refers to the use of the analytical procedure in different laboratories, as in a collaborative study. Intermediate precision (also known as ruggedness) expresses withinlaboratory variation, as on different days, or with different analysts or equipment within the same laboratory. Repeatability refers to the use of the analytical procedure within a laboratory over a short period of time using the same analyst with the same equipment.定義—分析方法的精密度是單個檢測結(jié)果間的一致程度，當方法重復使用于同一樣品的多個樣品時。精密度可以是在正常操作條件下，分析方法重現(xiàn)性和重復性程度的測量。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。Chromatography其可以評估。對于色譜方法，至關重要的。Data Elements Required for Validation驗證需求數(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:法定的檢測要求從高度萃取的分析測定到特征的主觀評價變化。本章節(jié)包括了最常用的檢測分類，驗證資料中需求。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定These procedures include quantitative assays and limit tests.這些方法包括定量地含量測定和限度測定。Table 2表2中列出是每一分類需求的數(shù)據(jù)組成。 May be required, depending on the nature of the specific test.lVerification of Compendial Proceduresfor 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。當前法定方法也是法規(guī)的主題，需要在實際條件下證明。適當?shù)奈募托碌幕蛐薷暮蟮姆ǘǖ姆椒ㄒ恢?。check for your question in the FAQsPage 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