穩(wěn)定性試驗方案

1、StabilityStudyProtocolforExhibitBatchofChloroquinePhosphateTabletsUSP,250mg規(guī)格為250mg的USP磷酸氯喹片長期、中期及加速穩(wěn)定性研究方案ProjectNo.項目號DP-ST-001-2008PreparedBy:Date:起草者：日期：ReviewedByQA:Date:審核者：日期：ApprovedBy:Date:批準者：日期：StartingDate:CompletedDate:開始日期：結束日期：Contents目錄1. Purpose目的1Scope范圍.12. References參考資料.1General

2、Information基本信息.12.1 StabilitySamples穩(wěn)定性研究樣品12.2 ProductOutline樣品概述.22.3 Formulation處方22.4 Container-ClosureSystems包裝3Labeling標簽.32.5 SamplesandPackage樣品與包裝4StabilityTesting穩(wěn)定性測試42.6 SampleReceiptandStorage樣品接收與儲存42.7 StorageConditionsandTestingTimePoints儲存條件與檢測時間點42.8 Sampling取樣52.9 TestingMatrix穩(wěn)定

3、性測試項目表62.10 ParametersandAcceptaneeCriteria檢測項目及質量標準62.11 Degradationproducts降解產物7DataPresentation數據匯總73. Reporting報告73.1 IntermediateReports中期報告73.2 SummaryReport總結報告73.3 StabilityDocuments穩(wěn)定性文件夾7Appendix附件81. Purpose目的ThepurposeofstabilitytestingistoprovideevideneeofhowtheQuality,Strength,Degradat

4、ionProductsandPurityoftheChloroquinePhosphateTabletsUSP,250mgwillchangewithtimeundertheinflueneeofenvironmentalroomtemperatureandrelativehumidityconditions.Datacollectedfromthestabilitystudywillenablerecommendedstorageconditionsandprovidejustificationforestablishingandsubmittingthedatatoregulatoryau

5、thoritiesforapprovingtheshelflifeformarketingpurposes.Inaddition,3monthsofthestabilitydatawillbesubmittedtoUSFDAasrequiredforsubmissionpurposesoftheANDAapplication.此穩(wěn)定性研究的目的是為了考察磷酸氯喹片在環(huán)境因素的影響下(例如：溫度和濕度)其性質、規(guī)格、降解產物和含量等隨時間而變化的規(guī)律，依據穩(wěn)定性研究的數據確定該產品的儲藏條件和有效期。2. Scope范圍ThisprocedureisapplicabletoFinishedPro

6、ductStabilityLabatHisunPharmaceutical(Hangzhou)Co.Ltd.Fuyang,Hangzhou.適用于浙江臺州海正藥業(yè)成品藥穩(wěn)定性實驗室。3. References參考資料ICHHarmonizedTripartiesGuidelineforStabilityTestingofNewDrugSubstancesandDrugProduct06,2003.ICHQ1A(R2)新原料藥和新制劑的穩(wěn)定性測試指南06,2003.ICHQ1A(R2)ASSAYMETHODVALIDATIONREPORTFORCHLOROQUINEPHOSPHATE,USP,A

7、PIANDCHLOROQUINEPHOSPHATE,USPTABLETS,250mgAND500mg.(ARD-VDR-FPTM025A)磷酸氯喹原料藥、250mg和500mg片的含量測定方法驗證報告。3.1 RELATEDSUBSTANCESMETHODVALIDATIONREPORTFORCHLOROQUINEPHOSPHATE,USP,APIANDCHLOROQUINEPHOSPHATE,USPTABLETS,250mgAND500mg.(ARD-VDR-FPTM025B)磷酸氯喹原料藥、250mg和500mg片有關物質方法驗證報告。3.2 DISSOLUTIONMETHODVALIDATIONREPORTFORCHLOROQUINEPHOSPHATE,USPTABLETS,250mgAND500mg.(ARD-VDR-FPTM025C)磷酸氯喹250mg和500mg片溶出度方法驗證報告。4. GeneralInformation基本信息4.1StabilitySamples穩(wěn)定性樣品OneExhibitBatchfor250mgstrengthwillbeincludedinthestab