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Prepared By: Date:起草者：日期：Reviewed By QA: Date:审核者：日期：Approved By: Date:批准者：日期：Starting Date: Completed Date:开始日期：结束日期：Contents目录1. Purpose目的 (1)2. Scope范围 (1)3. References参考资料 (1)4. General Information基本信息 (1)4.1 Stability Samples稳定性研究样品 (1)4.2 Product Outline样品概述 (2)4.3 Formulation处方 (2)4.4 Container-Closure Systems包装 (3)4.5 Labeling标签 (3)4.6 Samples and Package样品与包装 (4)5. Stability Testing稳定性测试 (4)5.1 Sample Receipt and Storage样品接收与储存 (4)5.2 Storage Conditions and Testing Time Points储存条件与检测时间点 (4)5.3 Sampling取样 (5)5.4 Testing Matrix稳定性测试项目表 (6)5.5 Parameters and Acceptance Criteria检测项目及质量标准 (6)5.6 Degradation products降解产物 (7)6. Data Presentation数据汇总 (7)7. Reporting报告 (7)7.1 Intermediate Reports中期报告 (7)7.2 Summary Report总结报告 (7)7.3 Stability Documents稳定性文件夹 (7)8. Appendix附件 (8)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。
2.Scope范围This procedure is applicable to Finished Product Stability Lab at Hisun Pharmaceutical (Hangzhou) Co.Ltd. Fuyang, Hangzhou.适用于浙江台州海正药业成品药稳定性实验室。
3.References参考资料3.1 ICH Harmonized Triparties Guideline for Stability Testing of New Drug Substances and DrugProduct06, 2003. [ICH Q1A (R2)]新原料药和新制剂的稳定性测试指南06, 2003. [ICH Q1A(R2)]3.2 ASSAY METHOD V ALIDATION REPORT FOR CHLOROQUINE PHOSPHATE, USP, API ANDCHLOROQUINE PHOSPHATE, USP TABLETS, 250 mg AND 500 mg. (ARD-VDR-FPTM025A) 磷酸氯喹原料药、250mg和500mg片的含量测定方法验证报告。
3.3 RELATED SUBSTANCES METHOD V ALIDATION REPORT FOR CHLOROQUINEPHOSPHATE, USP, API AND CHLOROQUINE PHOSPHATE, USP TABLETS, 250 mg AND 500 mg.(ARD-VDR-FPTM025B)磷酸氯喹原料药、250mg和500mg片有关物质方法验证报告。
3.4 DISSOLUTION METHOD V ALIDATION REPORT FOR CHLOROQUINE PHOSPHATE, USPTABLETS, 250 mg AND 500 mg. (ARD-VDR-FPTM025C)磷酸氯喹250mg和500mg片溶出度方法验证报告。
4.General Information基本信息4.1Stability Samples稳定性样品4.1.1 One Exhibit Batch for 250mg strength will be included in the stability study.规格为250mg的磷酸氯喹片各一批。
4.1.2 One batch of 250mg reference product will also be placed on stability study.规格为250mg和的磷酸氯喹对照制剂各一批。
4.2Product Outline样品信息Batch No.批号Strength规格(mg)Package Size包装规格Batch Size批量(Tablets)Mfg. Date生产日期Pkg. Date包装日期Manufacturer生产商25050Tablets/ Bottle360,,000Hisun海正100 Tablets/ Bottle500 Tablets/ Bottle61924A 250 50Tablets/ Bottle NA NA NA West-ward 4.3Formulation处方4.3.1The formulation of Chloroquine Phosphate USP Tablets, 250 mg, is as follows:规格为250mg的USP磷酸氯喹片处方如下：Table 1. Formula and batch sizeBatch size: 360,000 tablets ( 172.8 Kg )成分Ingredientsmg / 片mg / tabletKg / 批Kg / batchManufacturer原料药API*250 90IPCA微晶纤维素(102) MCC (Type 102) 154 55.44JRS二水磷酸氢钙Dibasic Calcium Phosphate Dihydrate 40 14.4JRS滑石粉Talc 24 8.64Merck 胶体二氧化硅Colloidal Silicon Dioxide (Aerosil 200) 4.8 1.728Degussa硬脂酸镁Magnesium Stearate 7.2 2.592Peter Greven总量T otal 480 172.8 4.4不适用4Container-Closure Systems 包装Packing Material 包材Batch No.批号Packing Material Description包材描述Manufacturer供应商60 cc HDPE bottle 60 cc HDPE瓶WE070601Bottle: 60 cc opaque white HDPE round bottle瓶：60cc白色不透明HDPE圆瓶Cap: φ32 mm opaque white CRC cap, with inductionsealing盖：φ32mm白色不透明CRC圆盖，带内封Triveni PolymersPvt. Ltd (Bottle)VBC Inc. (CRC Cap)Tekniplex (Liner)上海海昌120 cc HDPE bottle 120 cc HDPE瓶KQ080101Bottle: 120 cc opaque white HDPE round bottle瓶：120cc白色不透明HDPE圆瓶Cap: φ36 mm opaque white CRC cap, with inductionsealing盖：φ36mm白色不透明CRC圆盖，带内封Triveni PolymersPvt. Ltd (Bottle)VBC Inc. (CRC Cap)Tekniplex (Liner)上海海昌450 cc HDPE bottle 450 cc HDPE瓶WA080101Bottle: 450 cc opaque white HDPE round bottle瓶：450cc白色不透明HDPE圆瓶Cap: φ58 mm opaque white CT cap, with inductionsealing盖：φ58mm白色不透明CT圆盖，带内封Triveni PolymersPvt. Ltd (Bottle andCap)Tekniplex (Liner)上海海昌4.5Labeling标签The Product Name, Batch Number, Strength, Storage Condition, Package Type, No. and Stored by/ Store Date will be included on the label.标签应包括品名、批号、规格、储存条件、包装类型、编号及储存人/日期。