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1、原料藥主檔案(DMF)技術資料查檢表編號No.項目Items說明Note資料頁碼Page一I.封面Coverpage送審資料封面應繕寫：申請公司名、原料藥主檔案(DMF)資料、藥品名稱(含中英文)、送審日期、若委託製造應註明製造廠名。Thefollowingshouldbeincluded:Nameandaddressofcorporateheadquartersandthemanufacturer,identificationofsubmission:DMFTechnicalDocumentforActivePrincipleIngredient,nameof
2、subjectAPI,dateofsubmission,andnameoforiginalequipmentmanufacturer,ifany.二II.目錄Tableofcontents三III.縮寫對照表Abbreviation四IV.摘要Abstract1.主成分Activesubstance化學結構(包括立體結構)Chemicalstructureincludingstereochemistry若化合物具光學活性者須明確標示其立體結構Identifyingchiralcenters,cis-transisomerism,etc化學名Chemicalnam
3、e學名、原廠名、別名、CAS編碼、廠內代碼等Genericname,proprietaryname,chemicalname,codenumber,andChemicalAbstractsService(CAS)number,ifavailable分子式Molecularformula分子量Molecularweight外觀性狀Description外觀、顏色及物理化學性質等Appearance,color,physico-chemicalproperties,etc.2原料藥簡介BriefdescriptionofsubjectAPI3藥理作用機轉及臨床用途M
4、echanismsofpharmacologicalactionandclinicaluses4製造方法依據Referencedmethodssupportingthemanufacture(1)專利、文獻來源。(2)全文參考文獻影本列為本表第十四項資料併送。Patentsandliteraturereferences.PhotocopiesoffulltextattachedforItemXIV五V.製造說明Descriptionofmanufacturingprocesses1原料及試劑名稱Namesofstartingmaterials,solvents,
5、reagents,auxiliarymaterialsandotheringredients2B.反應方程式Syntheticormanufacturingroute反應方程式需涵蓋反應條件、實際下料量、莫耳數及產率(含計算式)等。Includeschemicalstructuresofreactants(i.e.,startingmaterialsandintermediates,andalsomoleculesincorporatedintothestructure)andproducts,stereochemicalconfigurations,where
6、applicable,intermediates(eitherinsituorisolated),andsolvents,catalysts,reagents,withwrittenstatementofreactionconditions(temperature,pH,time,pressure,etc.),actualquantity(weightandmoles)used,andyields(crudeand/orpurified;weightandpercent,shownbycalculation)3製造流程圖Diagrammaticflowchart
7、ofmanufacturingprocess六VI.原料藥之檢驗規格及成績書AnalyticalspecificationsandcertificateofanalysisofthesubjectAPI原料藥規格之依據：藥典收載之規格不得任意刪減，且應註明其版次。SpecificationsforthepharmacopeiaAPIshouldspecifytheeditionoftheofficialcompendiumandnotbechangedbyhaphazard.七VII.安定性試驗結果Stability(summaryandconclusion)至
8、少6個月(依安定性試驗基
