EDQM 质量综述 英文.pdfVIP

EDQM PA/PH/CEP(15)26 CertificationofSubstances Division QUALITY OVERALLSUMMARY Reference:EDQMguideline PA/PH/CEP(04) 1(as revised) Content ofthedossierforchemicalpurity and microbiologicalquality Substance name Monographn° Subtitle(ifany) Intended HolderoftheCEP Writtenby Qualification* Date (*):APPEND CV OF THE EXPERT 1 6 Page of EDQM PA/PH/CEP(15)26 CertificationofSubstances Division 2.3.SSUBSTANCE 2.3.S.1GeneralInformation Useofthesubstance:Route(s) ofadministration, maximumdaily dose. Commercialisationhistory:Summarisethe history basedonthetable intheapplicationform). 2.3.S.1.1Nomenclature (a) Recommended InternationalNon-proprietary name(INN): (b) Chemicalname(s): (c) Company orlaboratory code: (d) Othernon-proprietary name(s) (e.g., nationalname, USAN, BANetc.): (e) CAS No., MolecularFormula, MW: 2.3.S.1.3GeneralProperties Givesummariseddataon: (a) Physicaldescription(e.g., appearance, colour,physicalstate…). (b) Physicalform(e.g.,polymorphicform, solvate, hydrate):to becommentedespecially if requestedasgrade. (c) Solubility andotherpropertiesas necessary. (d) Particlesize:e.g. “non-micronised”, “micronised”orany gradeclaimedassubtitle. 2 6 Page of EDQM PA/PH/CEP(15)26 CertificationofSubstances Division 2.3.S.2Manufacture 2.3.S.2.1Manufacturer(s) (name, manufacturer)andsitesinvolved intheentire process Givethe name, addressand responsibility ofeachmanufacturer, including contractors, intermediate manufacturersandotherproposedproductionsitesorfacilities involved inprocess. 2.3.S.2.2Descriptionof M