有关物质方法确认方案.docx

METHOD VERIFICATION PROTOCOL FOR CHROMATOGRAPHIC PURITY OF CYTARABINE阿糖胞苷有关物质检查方法确认方案Area to be Distributed：AD, QA分发部门：分析部，质量保证部Print Name: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：Contents 目录一、Introduction3二、Scope3三、Responsibility3四、Definitions4五、Project5六、References25Introduction简介## is in the process of developing Cytarabine Injection, a liquid product for parenteral administration, for ##. Cytarabine is a chemotherapy agent with a molecular weight of 243.2. The API from Zhejiang Hisun Pharmaceutical Co. Ltd, which is approved by FDA, is used for Cytarabine Injection by Lummy.The Chromatographic purity method for Cytarabine is the method in the current USP34. The HPLC method for Chromatographic purity test of Cytarabine is a quantitative method. The method will be verified according to USP1226, including system suitability, specificity, LOD, LOQ, precision, solution stability and mobile phase stability.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USP1226，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。 Scope范围This protocol applies to the verification for chromatographic purity of cytarabine.该方案适用于阿糖胞苷色谱纯度的方法确认。Responsibility职责Name姓 名Department所在部门Title职称/职务Responsibility职 责Group leader, responsible for approve of protocols, records and reports, and organize the implementation of the protocol.组长，负责方案、记录和报告的审查批准并组织方案的实施。 Initiate and implement the protocol起草并执行方案Approve protocols, records and reports方案、记录和报告的审查批准Monitor the implementation of the protocol监督确认方案的实施Definitions 定义 1Limit of Detection (LOD)检测限（LOD）The limit of detection of an individual analytical procedure is the lowest amount of analyte in a sample which can be detected but not necessarily quantitated as an exact value.分析规程中的检测限是指样品中的被分析物在该分析方法中能被检测，但不需要准确定量的最低浓度。The detection limit is determined by analyzing samples with known concentrations of analyte and by es