本人在药企工作，目前很多原辅料的元素杂质检测都是标准加入法，药典有指导原则但是本人英语不好 不能理解其中意思，如各位老师有中文版不胜感激。 站短联系。就是验证与确认的内容不是仪器3Q 嫌麻烦可以只翻译标准加入法内容还有最后一段的确认必须包含什么项目来着。 附件为英文原版 您把需要的部分单独打字贴出来，大家可以分几段话翻译。一大段可能很多不好弄。 1）准确度 In standard addition methods, accuracyassessments are based on the final intercept concentration, not the recoverycalculated from the individual standard additions. 2）精密度 If validating a procedure by the method of standardadditions, the precision criterion applies to the final experimental result,not the accuracy of the individual standard addition levels. 3 ） QL Ifvalidating a procedure using the method of standard additions, the slope ofstandards applied to a solution of the test material is used. Other suitableapproaches can be used (see 〈1225〉). A measurement of a test solution preparedfrom a representative sample matrix spiked at the estimated QL concentrationmust be performed to confirm accuracy. If validating a procedure using themethod of standard additions, the validation criterion applies to the finalexperimental result, not the spike recovery of the individual standard additionlevels. Validation criteria: The analytical procedure shouldbe capable of determining the analyte precisely and accurately at a levelequivalent to 50% of the specification. 4） robustness The reliability of an analyticalmeasurement is demonstrated by deliberate changes to experimental parameters.For AA this can include but is not limited to sample preparation steps andheating programs, including atomization hold time or atomization temperature.Exercise caution when changing fuel and oxidant gas flows and burner hardware,because this could potentially create a flash-back condition. 5）确认 Verification U.S. Current Good Manufacturing Practicesregulations indicate that users of the analyticalprocedures, as described in USP-NF, are not required to validate theseprocedures if provided in a monograph. Instead, they must simply verify theirsuitability under actual conditions of use. The objective of an AA procedureverification is to demonstrate that the procedure, as prescribed in a specificmonograph, can be executed by the user with suitable accuracy, specificity,linearity, and precision using the instruments, analysts, and sample matricesavailable. According to Verification of Compendial Procedures 〈1226〉, if the verification of the compendial procedure by following themonograph is not successful, the procedure may not be suitable for use with thearticle under test. It may be necessary to develop and validate an alternativeprocedure as allowed in General Notices 6.30. Verification of compendial AA methodsshould, at a minimum, include the execution of the validation parameters forspecificity, linearity, accuracy, precision, and limit of quantitation, whenappropriate, as indicated in Validation.
最后一句，药典中AA方法的确认应至少包括专属性、线性、准确度、精密度、定量限。验证其适用性。（就是在本实验室的适用性）意译。 1） 准确度 In standard addition methods, accuracy assessments are based on the final intercept concentration, not the recovery calculated from the individual standard additions. 对于标准加入法来说,准确度的评估是基于最终的截距浓度,而非加标回收率。 2） 精密度 If validating a procedure by the method of standardadditions, the precision criterion applies to the final experimental result,not the accuracy of the individual standard addition levels. 验证标准加入法的精密度，要看最终的实验结果,而非加标水平的准确度。 这两个标准加入法，各位老师有什么想法吗?怎么实际操作呢。 当时翻译准确度与精密度这两项时，确觉很生拗，一来跟我们印象中的“准确度”与“精密度”的概念不同，二来对“截距浓度”与“实验结果”困惑，因为我认为“实验结果”就是“截距浓度”。是否如此？我希望能够得到了解这方面的老师的帮助，然一直未能如愿。由于时间、精力、工作局限及信心等原因应答者寥，其实也可以理解，不必深究。至于文中一再强调的加标回收率不必考虑，反正我们知道肯定跟它没关系。 现在想来，不如直接以我们头脑中本有的“准确度”与“精密度”概念来做它。“准确度”与真值相比（也许是要用到标准物质？），“精密度”看多次重复。我想天下“准确度”与“精密度”应该都是统一的，外文版也是如此。当然这只是推测，要是能够验证这个结论就好了！
1） 准确度 In standard addition methods, accuracy assessments are based on the final intercept concentration, not the recovery calculated from the individual standard additions. 对于标准加入法来说,准确度的评估是基于最终的截距浓度,而非加标回收率。 2） 精密度 If validating a procedure by the method of standardadditions, the precision criterion applies to the final experimental result,not the accuracy of the individual standard addition levels. 验证标准加入法的精密度，要看最终的实验结果,而非加标水平的准确度。 3 ）QL If validating a procedure using the method of standard additions, the slope of standards applied to a solution of the test material is used. Other suitable approaches can be used (see 〈1225〉). A measurement of a test solution prepared from a representative sample matrix spiked at the estimated QL concentration must be performed to confirm accuracy. If validating a procedure using the method of standard additions, the validation criterion applies to the final experimental result, not the spike recovery of the individual standard addition levels. Validation criteria: The analytical procedure should be capable of determining the analyte precisely and accurately at a level equivalent to 50% of the specification. 验证标准加入法时,要使用被测物质的溶液（消解液？）制作标曲，也可以采用其他合适的方法(见< 1225 >)。 先采用具有代表性的样品基质制备溶液，再按照估算浓度添加质控物，最后进行测量，以确认准确度。 如果要验证一个标准加入法的操作规程，评定标准是基于最终的实验结果,而非加标回收率。 验证标准:测试结果的准确度和精密度应该能够达到相当于规定要求的50%以上。 4） robustness The reliability of an analytical measurement is demonstrated by deliberate changes to experimental parameters.For AA this can include but is not limited to sample preparation steps and heating programs, including atomization hold time or atomization temperature.Exercise caution when changing fuel and oxidant gas flows and burner hardware,because this could potentially create a flash-back condition. 可以通过有意改变实验参数确证测试方法的可靠性。对AA，可以包括但不仅限于样品制备步骤和加热程序,包括原子化保持时间或原子化温度。当改变燃气和助燃气流量以及燃烧器硬件时要当心,因为这可能会导致回火。 5）确认 Verification U.S. Current Good Manufacturing Practices regulations indicate that users of the analytical procedures, as described in USP-NF, are not required to validate these procedures if provided in a monograph. Instead, they must simply verify their suitability under actual conditions of use. The objective of an AA procedure verification is to demonstrate that the procedure, as prescribed in a specific monograph, can be executed by the user with suitable accuracy, specificity,linearity, and precision using the instruments, analysts, and sample matrices available. According to Verification of Compendial Procedures 〈1226〉, if the verification of the compendial procedure by following the monograph is not successful, the procedure may not be suitable for use with the article under test. It may be necessary to develop and validate an alternative procedure as allowed in General Notices 6.30. Verification of compendial AA methods should, at a minimum, include the execution of the validation parameters for specificity, linearity, accuracy, precision, and limit of quantitation, when appropriate, as indicated in Validation. 美国现行的良好生产规范表明，使用诸如在USP-NF中所描述的分析方法的用户,无需验证这些由专著提供的规程。相反,他们只需验证这些规程在实际条件下的适用性即可。 AA规程验证的目的是想要证明用户使用现有的仪器、检测人员及简单的基质，根据一个专著提供的方法，能够在准确度、专一性、线性和精确度等方面满足要求。 根据药典规程中相关的验证要求< 1226 >,如果按照专著所描述的方法验证时不能成功,那么这个方法就不能用于生产，需要根据总则6.30开发和验证另一种方法。 药典中 AA方法的验证至少应包括在适当的时候进行特殊参数、线性、准确度、精度、和定量的极限的验证。
In standard addition methods, accuracy assessments are based on the final intercept concentration, not the recovery calculated from the individual standard additions.
对于标准加入法来说,准确度的评估是基于最终的截距浓度,而非加标回收率。
2） 精密度
If validating a procedure by the method of standardadditions, the precision criterion applies to the final experimental result,not the accuracy of the individual standard addition levels.
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