稳定性试验方案.docxVIP

Stability Study Protocol for Exhibit Batch of Chloroquine Phosphate Tablets USP, 250mg 规格为 250 mg 的USP 磷酸氯喹片 长期、中期及加速稳定性研究方案 $ Project No. Project No. 项目号 DP-ST-001-2008 / Prepared By: Date: 起草者： 日期： Reviewed By QA: 审核者： Date: 日期： Approved By: 批准者： Date: 日期： Starting Date: 开始日期： Completed Date: 结束日期： ` Contents 目 录 P u r p o s e 目 的 1 S c o p e 范 围 1 R e f e r e n c e s 参考资料 1 G e n e r a l I n f o r m a t i o n 基本信息 1 S t a b i l i t y S a m p l e s 稳定性研究样品 1 P r o d u c t O u t l i n e 样品概述 1 F o r m u l a t i o n 处方 1 C o n t a i n e r - C l o s u r e S y s t e m s 包装 1 L a b e l i n g 标 签 1 S a m p l e s a n d P a c ka g e 样品与包装 1 S t a b i l i t y Te s t i n g 稳定性测试 1 Sam pl e Rec ei pt and S to ra ge 样品接收 与储存 1 Storage Conditions and Testing Time Points 储存条件与检测时间点 1 S a m p l i n g 取样 1 Te s t i n g M a t r i x 稳定性测试项目表 1 Parameters and Acceptance Criteria 检测项目及质量标准 1 D e g r a d a t i o n p r o d u c t s 降解产物 1 D a t a P r e s e n t a t i o n 数据汇总 1 R e p o r t i n g 报告 1 I n t e r m e d i a t e R e p o r t s 中期报告 1 S u m m a r y R e p o r t 总结报告 1 S t a b i l i t y D o c u m e n t s 稳定性文件夹 1 A p p e n d i x 附件 1 Purpose 目的 The purpose of stability testing is to provide evidence of how the Quality, Strength, Degradation Products and Purity of the Chloroquine Phosphate Tablets USP, 250mg will change with time under the influence of environmental room temperature and relative humidity conditions. Data collected from the stability study will enable recommended storage conditions and provide justification for establishing and submitting the data to regulatory authorities for approving the shelf life for marketing purposes. In addition, 3 months of the stability data will be submitted to US FDA as required for submission purposes of the ANDA application. 此稳定性研究的目的是为了考察磷酸氯喹片在环境因素的影响下(例如：温度和湿度)其性质、规格、降解产物和含量等随时间而变化的规律，依据稳定性研究的数据确定该产品的储藏条件和 有效期。 Scope 范围 This procedure is applicable to Finished Product Stability Lab at Hisun Pharmaceutical (Hangzhou) Co. Ltd. Fuy