检验报告Certificateofanalysis简称COA分析报告单.doc

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//inspectingbasis//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appearanceofsolution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lossondrying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//meshsizePH值PHValue吸收系数absorptioncoefficient氯化物chloride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Calculatedontheanhydroussubstance应符合规定complieswiththeCRS//meettherequirements不少于nolessthan不多于nomorethan//NMT无negative有positive欧洲药典EurPh美国USP中国CH・P***J・P80—100目80—100mesh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CorrespondingtoReferenceSpectrum结果results符合规定conforms//complieswith//pass//meettherequirement结论CONCLUSION符合英国药典2000版complieswithBP2000化验员Analyst复核员Checker质保经理QAmanager//QAdirector。