稳定性试验方案

StabilityStudyProtocol稳定性方案ChloroquinePhosphateTabletsProtocolNo.:PRO-ST-001-2008(1.2)磷酸氯喹片方案编号：PRO-ST-001-2008(1.2)StabilityLab稳定性实验室StabilityStudyProtocolforExhibitBatchofChloroquinePhosphateTabletsUSP,250mg规格为250mg的USP磷酸氯喹片长期、中期及加速稳定性研究方案ProjectNo.项目号DP-ST-001-2008PreparedBy:Date:起草者：日期：ReviewedByQA:Date:审核者：日期：ApprovedBy:Date:批准者：日期：StartingDate:CompletedDate:开始日期：结束日期：StabilityStudyProtocol稳定性方案ChloroquinePhosphateTabletsProtocolNo.:PRO-ST-001-2008(1.2)磷酸氯喹片方案编号：PRO-ST-001-2008(1.2)StabilityLab稳定性实验室Contents目录1.Purpose目的…………………………………………………………………………………………12.Scope范围…………………………………………………………………………………………..13.References参考资料…………………………………………………………………………………..14.GeneralInformation基本信息………………………………………………………………………..14.1StabilitySamples稳定性研究样品…………………………………………………………14.2ProductOutline样品概述………………………………………………………………..……24.3Formulation处方………………………………………………………………………………24.4Container-ClosureSystems包装……………………………………………………………34.5Labeling标签…………………………………………………………………………………..34.6SamplesandPackage样品与包装………………………………………………………….45.StabilityTesting稳定性测试…………………………………………………………………………45.1SampleReceiptandStorage样品接收与储存……………………………………………45.2StorageConditionsandTestingTimePoints储存条件与检测时间点……………………45.3Sampling取样…………………………………………………………………………………55.4TestingMatrix稳定性测试项目表……………………………………………………………65.5ParametersandAcceptanceCriteria检测项目及质量标准………………………………65.6Degradationproducts降解产物……………………………………………………………76.DataPresentation数据汇总…………………………………………………………………………77.Reporting报告………………………………………………………………………………………77.1IntermediateReports中期报告………………………………………………………………77.2SummaryReport总结报告…………………………………………………………………77.3StabilityDocuments稳定性文件夹…………………………………………………………78.Appendix附件…………………………………………………………………………………………8StabilityStudyProtocol稳定性方案ChloroquinePhosphateTabletsProtocolNo.:PRO-ST-001-2008(1.2)磷酸氯喹片方案编号：PRO-ST-001-2008(1.2)StabilityLabPage1/9稳定性实验室1.Purpose目的ThepurposeofstabilitytestingistoprovideevidenceofhowtheQuality,Strength,DegradationProductsandPurityoftheChloroquinePhosphateTabletsUSP,250mgwillchangewithtimeundertheinfluenceofenvironmentalroomtemperatureandrelativehumidityconditions.Datacollectedfromthestabilitystudywillenablerecommendedstorageconditionsandprovidejustificationforestablishingandsubmittingthedatatoregulatoryauthoritiesforapprovingtheshelflifeformarketingpurposes.Inaddition,3monthsofthestabilitydatawillbesubmittedtoUSFDAasrequiredforsubmissionpurposesoftheANDAapplication.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ThisprocedureisapplicabletoFinishedProductStabilityLabatHisunPharmaceutical(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3.1ICHHarmonizedTripartiesGuidelineforStabilityTestingofNewDrugSubstancesandDrugProduct06,2003.[ICHQ1A(R2)]新原料药和新制剂的稳定性测试指南06,2003.[ICHQ1A(R2)]3.2ASSAYMETHODVALIDATIONREPORTFORCHLOROQUINEPHOSPHATE,USP,APIANDCHLOROQUINEPHOSPHATE,USPTABLETS,250mgAND500mg.(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。3.3RELATEDSUBSTANCESMETHODVALIDATIONREPORTFORCHLOROQUINEPHOSPHATE,USP,APIANDCHLOROQUINEPHOSPHATE,USPTABLETS,250mgAND500mg.(ARD-VDR-FPTM025B)磷酸氯喹原料药、250mg和500mg片有关物质方法验证报告。3.4DISSOLUTIONMETHODVALIDATIONREPORTFORCHLOROQUINEPHOSPHATE,USPTABLETS,250mgAND500mg.(ARD-VDR-FPTM025C)磷酸氯喹250mg和500mg片溶出度方法验证报告。4.GeneralInformation基本信息4.1StabilitySamples稳定性样品4.1.1OneExhibitBatchfor250mgstrengthwillbeincludedinthestabilitystudy.规格为250mg的磷酸氯喹片各一批。4.1.2Onebatchof250mgreferenceproductwillalsobeplacedonstabilitystudy.规格为250mg和的磷酸氯喹对照制剂各一批。StabilityStudyProtocol稳定性方案ChloroquinePhosphateTabletsProtocolNo.:PRO-ST-001-2008(1.2)磷酸氯喹片方案编号：PRO-ST-001-2008(1.2)StabilityLabPage2/9稳定性实验室4.2ProductOutline样品信息BatchNo.批号Strength规格(mg)PackageSize包装规格BatchSize批量(Tablets)Mfg.Date生产日期Pkg.Date包装日期Manufacturer生产商25050Tablets/Bottle360,,000Hisun海正100Tablets/Bottle500Tablets/Bottle61924A25050Tablets/BottleNANANAWest-ward4.3Formulation处方4.3.1TheformulationofChloroquinePhosphateUSPTablets,250mg,isasfollows:规格为250mg的USP磷酸氯喹片处方如下：Table1.FormulaandbatchsizeBatchsize:360,000tablets(172.8Kg)成分Ingredientsmg/片mg/tabletKg/批Kg/batchManufacturer原料药API*25090IPCA微晶纤维素(102)MCC(Type102)15455.44JRS二水磷酸氢钙DibasicCalciumPhosphateDihydrate4014.4JRS滑石粉Talc248.64Merck胶体二氧化硅ColloidalSiliconDioxide(Aerosil200)4.81.728Degussa硬脂酸镁MagnesiumStearate7.22.592PeterGreven总量Total480172.84.4不适用StabilityStudyProtocol稳定性方案ChloroquinePhosphateTabletsProtocolNo.:PRO-ST-001-2008(1.2)磷酸氯喹片方案编号：PRO-ST-001-2008(1.2)StabilityLabPage3/9稳定性实验室4Container-ClosureSystems包装PackingMaterial包材BatchNo.批号PackingMaterialDescription包材描述Manufacturer供应商60ccHDPEbottle60ccHDPE瓶WE070601Bottle:60ccopaquewhiteHDPEroundbottle瓶：60cc白色不透明HDPE圆瓶Cap:φ32mmopaquewhiteCRCcap,withinductionsealing盖：φ32mm白色不透明CRC圆盖，带内封TriveniPolymersPvt.Ltd(Bottle)VBCInc.(CRCCap)Tekniplex(Liner)上海海昌120ccHDPEbottle120ccHDPE瓶KQ080101Bottle:120ccopaquewhiteHDPEroundbottle瓶：120cc白色不透明HDPE圆瓶Cap:φ36mmopaquewhiteCRCcap,withinductionsealing盖：φ36mm白色不透明CRC圆盖，带内封TriveniPolymersPvt.Ltd(Bottle)VBCInc.(CRCCap)Tekniplex(Liner)上海海昌450ccHDPEbottle450ccHDPE瓶WA080101Bottle:450ccopaquewhiteHDPEroundbottle瓶