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1、SOPNo.:US-AD-PT-US002-02METHODVERIFICATIONPROTOCOLFORCHROMATOGRAPHICPURITYOFCYTARABINE阿糖胞苷有关物质检查方法确认方案AreatobeDistributed：AD,QA分发部门：分析部，质量保证部PrintName:姓名：Title:职位：Signature:签名：Date:日期：Author:起草人：Approver:批准人：Approver:批准人：Reviewer:审核人：Approver:批准人：Pleasecheckthecurr
2、entversioninyourdepartmentbeforeusing.请使用部门的当前版本25of26SOPNo.:US-AD-PT-US002-02Contents目录一、Introduction3二、Scope3三、Responsibility3四、Definitions4五、Project5六、References25Pleasecheckthecurrentversioninyourdepartmentbeforeusing.请使用部门的当前版本25of26SOPNo.:US-AD-PT-US002-02Int
3、roduction简介##isintheprocessofdevelopingCytarabineInjection,aliquidproductforparenteraladministration,for##.Cytarabineisachemotherapyagentwithamolecularweightof243.2.TheAPIfromZhejiangHisunPharmaceuticalCo.Ltd,whichisapprovedbyFDA,isusedforCytarabineInjectionbyLummy
4、.TheChromatographicpuritymethodforCytarabineisthemethodinthecurrentUSP34.TheHPLCmethodforChromatographicpuritytestofCytarabineisaquantitativemethod.ThemethodwillbeverifiedaccordingtoUSP<1226>,includingsystemsuitability,specificity,LOD,LOQ,precision,solutionstabilit
5、yandmobilephasestability.阿糖胞苷注射液是一种临床用液体产品，##药业为##药业研发该品种。阿糖胞苷是一种化学药，分子量为243.2。莱美研发阿糖胞苷注射液所用原料药来源于浙江海正药业，是获得了FDA认证的原料药。阿糖胞苷色谱纯度检测方法来自现行USP34，色谱纯度检查方法，是定量检测方法。依照USP<1226>，本次确认内容包括系统适用性，专属性，检测限,定量限、精密度、溶液稳定性和流动相稳定性。一、Scope范围Thisprotocolappliestotheverificationforchro
6、matographicpurityofcytarabine.该方案适用于阿糖胞苷色谱纯度的方法确认。二、Responsibility职责Name姓名Department所在部门Title职称/职务Responsibility职责Groupleader,responsibleforapproveofprotocols,recordsandreports,andorganizetheimplementationoftheprotocol.组长，负责方案、记录和报告的审查批准并组织方案的实施。Initiateandimplemen
7、ttheprotocol起草并执行方案Approveprotocols,recordsandreports方案、记录和报告的审查批准Monitortheimplementationoftheprotocol监督确认方案的实施三、Definitions定义Pleasecheckthecurrentversioninyourdepartmentbeforeusing.请使用部门的当前版本25of26SOPNo.:US-AD-PT-US002-021LimitofDetection(LOD)检测限（LOD）Thelimitofde
8、tectionofanindividualanalyticalprocedureisthelowestamountofanalyteinasamplewhichcanbedetectedbutnotnecessarilyquantitatedasanexactvalue.分析规程中的检测限
