【正文】 分析樣品組成了完整的系統(tǒng)。其可以評估。特別方法需要建立系統(tǒng)適應性檢測取決于需要評估的方法的類別。對于色譜方法，至關重要的。USP的遞交應注意系統(tǒng)適應性的要求，色譜法621Data Elements Required for Validation驗證需求數據組成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。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。本章節(jié)包括了最常用的檢測分類，驗證資料中需求。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定的分析方法。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。Category III—Analytical procedures for determination of performance characteristics (., dissolution, drug release).分類 III——用于測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For each category, different analytical information is needed. Listed inTable 2are data elements that are normally required for each of these categories.對于每一分類，需要不同的分析資料資料。表2中列出是每一分類需求的數據組成。Table 2. Data Elements Required for Validation表2 驗證需求的資料組成AnalyticalPerformanceCharacteristics分析性能參數Category I分類ICategory II分類IICategory III分類IIICategory IV分類IVQuantitative定量LimitTests限度Accuracy準確度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l May be required, depending on the nature of the specific test.l 取決于特定檢測的性質，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.對已經建立的總的方法（如，水分的滴定測定，細菌內毒素）證明以建立其系統(tǒng)適應性，如其準確度（適當干預的存在），當用于新產品或原輔料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 (seeVerification of Compendial Procedures1226for 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。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。當前法定方法也是法規(guī)的主題，需要在實際條件下證明。見1226。適當的文件應和新的或修改后的法定的方法一致。Auxiliary Information— Pleasecheck for your question in the FAQsbefore contacting USP.輔助信息——在聯系USP前請核對FAQ中你們的問題Topic/Question話題/問題Contact聯系Expert Committee專家委員會General Chapter總章節(jié)Horacio N. Pappa, .Senior Scientist and Latin American Liaison13018168319(GC05) General Chapters 05USP32–NF27Page 733Pharmacopeial Forum: Volume No. 34(3) Page 794內容總結（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據支持以證明其有效，這是十分必要的