江苏恒瑞医药股份有限公司的药品质量标准分析方法验证qc827b49

1、江苏恒瑞医药股份JIANGSU HENGRUI MEDICINE CO., LTD.管理文件和管理程序Administration Document & Management Procedure质量控制Quality Control 文件名：File Name:药品质量标准分析方法验证 Validation of analytical method adopted in pharmaceutical quality specification 文件号：QC-827BFile Code:页 号：Page 1 of 7 Pages:分发部门：Distribution 质量部 Quality department 执行日期：Executive date:2005年8月15日变更记载/History文件名称：File Name：文件号：File Code:执行日期:Implement Date变更原因:Rationale:药品质量标准分析方法验证QC-827B2005-08-15版面格式与总公司统一起草/日期Written By/Date审核/日期Reviewed By/Date批准/日期Ac

2、cepted By/DateQC-827B Page 2 of 71.目的 Purpose 证明采用的方法适合于相应检测要求。To testify the adopted methods meet corresponding detection requirements. 2.范围 Scope 适用于鉴别试验，杂质定量或限度检查，原料或制剂中有效成分含量测定，制剂中其它成分（如降解产物、防腐剂等）的测定。药品溶出度、释放度等功能检查中的溶出量等测试方法，以及微生物限度、细菌内毒素、无菌、清洗验证中的检验方法。It is applicable to identification; quantification or limit test of impurities; content determination of the active ingredient in drug substance or preparation and that of other components (degradation products, antiseptics etc. ) in the prepa

3、ration; dissolution and release test of pharmaceuticals; microbial limit test; tests for bacterial endotoxin, sterility; and test of cleaning validation. 3.程序 Procedures 化学检验方法 Chemical examination methods准确度 Accuracy 准确度系指用该方法测定的结果与真实值或参考值接近的程度,一般以回收率(%)表示。The accuracy of an analytical method is the closeness of test results obtained by that method to the true value or the reference value. Accuracy is often expressed as percent recovery value. 1. 含量测定方法的准确度Accuracy of the method for content det

4、ermination 原料药可用已知纯度的对照品或样品进行测定,或用本法所得结果与已建立准确度的另一方法测定的结果进行比较。The accuracy for drug substance may be determined with a reference substance or sample with known purity, or by comparing the result obtained by this method with the result obtained by another method of which the accuracy has been established. 制剂可用含已知量被测物的各组分混合物进行测定，或向制剂中加入已知量的被测物进行测定，或与另一已建立准确度的方法比较结果。The accuracy for drug preparation may be determined with the mixture of components, to which known amounts of analyte have been added.

5、 If it is not possible to obtain all the components, the accuracy may be determined by adding known amounts of analyte to the preparation, or by comparing the result obtained by this method with the result obtained by another method whose accuracy has been known. 如该法已建立了精密度、线性和专属性，准确度不必再做。When the precision, linearity and specificity of a method have been developed, then it is unnecessary to determine the accuracy because the accuracy can be calculated. 2. 杂质定量测定的准确度Accuracy of quantitative dete

6、rmination of impurity可向原料药或制剂中加入已知量杂质进行测定，如不能得到杂质或降解产物，可用本法测定结果与另一成熟的方法进行比较。如不能测得杂质或降解产物的相对响应因子，则可用原料药的响应因子。应明确证明单个杂质和杂质总量相当于主成分的重量比（%），或是面积比（%）。The accuracy may be determined by adding known amounts of impurity to the drug substance or preparation. When the impurity or degeneration product is unavailable, the accuracy may be determined by comparing the result obtained by this method with the result obtained by another method whose accuracy has been known. When the impurity or degeneration produ

7、ct is unavailable, the accuracy may be determined by comparing the result obtained by this method with the result obtained by another method whose accuracy has been known. When the impurity or degeneration product is unavailable, the accuracy may be determined by comparing the result obtained by this method with the result obtained by another method whose accuracy has been known. The response factor of the drug substance may be used if the response factor or the relative response factor of the i

8、mpurity or degeneration product to the drug substance can not be determined. The percent ratio of weight or area of a single impurity and total impurities to that of the active ingredient should be testified definitely. 3. 数据要求Requirement for the data 在方法范围内，至少用9次测定结果进行评价，如制备3个不同浓度级别的样品，各测定3次。计算9个测定结果的回收率及相对标准偏差，均应在规定限度之内。In specified range, the accuracy should be evaluated using at least 9 testing results of the sample, 3 testing solutions of each concentration level (3 different concentration levels in all) are prepared and measured. The recovery value and RSD of testing results shall be calculated and within specified ranges. 起草/日期Written By/Date审核/日期Reviewed By/Date批准/日期Accepted By/Date精密度 Precision QC-827B Page 3 of 7精密度系指在规定的测试条件下,同一个均匀样品,经多次取样测定所得结果之间的接近程度,用偏差、标准偏差或相对标准偏差表示。含量测定和杂质定量测定应考查方法的精密度。The precision of an analytical method is the degree of agreement among individual test result when the procedure is applied repeat

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