检验报告-Certificate-of-analysis-简称COA分析报告单.doc

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1、检验报告Certificateofanalysis简称COA分析报告单化工有限公司chemicalCO.,LTD制药(药业)有限公司Pharmaceuticalco.,Ltd.化工厂CHEMICALPLANT精细化工有限公司FINECHEMICALCO.,LTD品名PRODUCT//title批号batchNO.生产日期manufacturingdate//manu.Date检验日期Analysisdate有效期Expdate//expirydate检验标准qualitystandard//inspectingbas

2、is//Specification数量QUANTITY报告日期reportdate包装规格package企业标准CompanyStandard//enterprisestandard检查项目testitems//analyticalitems性状appearance//characteristics//description//Character分子式molecularformula分子量molecularwt化学式Chemicalformula鉴别identification溶液外观appearanceofsolu

3、tion澄清度&颜色clarity&color白色或类白色结晶粉末whiteoralmostwhitecrystallinepowder味微苦　alittlebittertaste无色无味odorless,smelless酸碱度acidityandalkalinity铅盐Plumbumsalts砷盐Arsoniumsalts有关物质relatedsubstances分为：individualimpuritysubstanceNMT….；totalimpuritysubstanceNMT。。。干燥失重lossondry

4、ing炽灼残渣residueonignition重金属heavymetals溶剂残留solventresidue有机挥发性物质organicvolatileimpurities溶解度　solubility熔点　meltingpoint旋光度　opticalrotation比旋光度specificrotation灰分sulphatedash水分　watercontent//moisture粒度　particlessize／／ＭＥＳＨ　ＳＩＺＥPH值PHValue吸收系数absorptioncoefficient氯化物c

5、hloride硫酸盐sulphate农药残留　residueofpesticide微生物限度细菌MicrobialLimitbacteria细菌总数　totalplatecount霉菌和酵母菌yeast&mold//Mildew&Microzyme大肠杆菌　Ｅ.ｃｏｉｌ//Esherichiacoli沙门氏菌　salmonella含量　ＡＳＳＡＹ　纯度purity按归一法计算CalculatedontheNormalizationmethod按干燥品计算Calculatedontheanhydroussubstanc

6、e应符合规定　complieswiththeCRS//meettherequirements不少于　nolessthan不多于　nomorethan//NMT无　negative有　positive欧洲药典　Ｅｕｒ　Ｐｈ　美国　ＵＳＰ　中国　ＣＨ.P***　Ｊ.Ｐ８０－１００目　８０－１００　mesh澄清无色　clearandcolorless紫外灯　Ultravioletraylamp溶于　solublein..易溶于　freelysolublein..微溶于　sparingsolublein..与对照品图谱一致　

7、CorrespondingtoReferenceSpectrum结果　results符合规定　conforms//complieswith//pass//meettherequirement　结论　ＣＯＮＣＬＵＳＩＯＮ符合英国药典２０００版　ｃｏｍｐｌｉｅｓ　withBP2000化验员　Analyst复核员　Ｃhecker质保经理　ＱＡmanager//QAdirector