稳定性试验方案.doc

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1、..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：word资料..Contents目录1.Purpose目的………………

2、…………………………………………………………………………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………………………………………………………………..……14

3、.3Formulation处方………………………………………………………………………………14.4Container-ClosureSystems包装……………………………………………………………14.5Labeling标签…………………………………………………………………………………..14.6SamplesandPackage样品与包装………………………………………………………….15.StabilityTesting稳定性测试…………………………………………………………………………15.1SampleReceiptandStorage样品接收与储

4、存……………………………………………15.2StorageConditionsandTestingTimePoints储存条件与检测时间点……………………15.3Sampling取样…………………………………………………………………………………15.4TestingMatrix稳定性测试项目表……………………………………………………………15.5ParametersandAcceptanceCriteria检测项目及质量标准………………………………15.6Degradationproducts降解产物……………………………………………………………16.

5、DataPresentation数据汇总…………………………………………………………………………17.Reporting报告………………………………………………………………………………………17.1IntermediateReports中期报告………………………………………………………………17.2SummaryReport总结报告…………………………………………………………………17.3StabilityDocuments稳定性文件夹…………………………………………………………18.Appendixword资料..附件…………………………………………

6、………………………………………………1word资料..Purpose目的ThepurposeofstabilitytestingistoprovideevidenceofhowtheQuality,Strength,DegradationProductsandPurityoftheChloroquinePhosphateTabletsUSP,250mgwillchangewithtimeundertheinfluenceofenvironmentalroomtemperatureandrelativehumidityconditions.Datacol

7、lectedfromthestabilitystudywillenablerecommendedstorageconditionsandprovidejustificationforestablishingandsubmittingthedatatoregulatoryauthoritiesforapprovingtheshelflifeformarketingpurposes.Inaddition,3monthsofthestabilitydatawillbesubmittedtoUSFDAasrequiredforsubmissionpurpose

8、softheANDAapplication.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