药品检验报告英语药品检验报告英语.doc

检验报告??Certificate of analysis 化工有限公司 chemical CO. , LTD制药(药业)有限公司 Pharmaceutical co. ,Ltd.化工厂 CHEMICAL PLANT 精细化工有限公司 FINE CHEMICAL CO., LTD品名 PRODUCT //title批号 batch NO.生产日期 manufacturing date // manu. Date 检验日期 Analysis date有效期 Exp date // expiry date 检验标准 quality standard //inspecting basis //Specification数量 QUANTITY? ?报告日期 report date??包装规格 package 企业标准Company Standard//enterprise standard检查项目 test items//analytical items 性状 appearance // characteristics//description//Character分子式 molecular formula??分子量 molecular wt 化学式Chemical formula 鉴别 identification??溶液外观 appearance of solution 澄清度颜色clarity color白色或类白色结晶粉末white or almost white crystalline powder 味微苦　a little bitter taste 无色无味 odorless,smelless酸碱度 acidity and alkalinity 铅盐Plumbum salts? ? 砷盐Arsonium salts有关物质 related substances 分为：individual impurity substance NMT….；total impurity substance NMT。。。干燥失重 loss on drying 炽灼残渣residue on ignition 重金属 heavy metals 溶剂残留 solvent residue 有机挥发性物质 organic volatile impurities溶解度　solubility 熔点　melting point 旋光度　optical rotation 灰分 sulphated ash 水分　water content //moisture粒度　particles size ／／ＭＥＳＨ　ＳＩＺＥPH值PH Value 吸收系数absorption coefficient氯化物 chloride??硫酸盐sulphate??农药残留　 residue of pesticide 微生物限度细菌Microbial Limit bacteria细菌总数　total plate count 霉菌和酵母菌yeast mold //MildewMicrozyme大肠杆菌　Ｅ.ｃｏｉｌ //Esherichia coli沙门氏菌　salmonella 含量　ＡＳＳＡＹ　按归一法计算 Calculated on the Normalization method按干燥品计算 Calculated on the anhydrous substance应符合规定　complies with the CRS //meet the requirements 不少于　no less than 不多于　no more than //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　clear and colorless 紫外灯　Ultraviolet ray lamp 溶于　soluble in ..易溶于　freely soluble in.. 微溶于　sparing soluble in ..与对照品图谱一致　Corresponding to Reference Spectrum 结果　results 符合规定　conforms // complies with // pass //meet the requirement 　结论　ＣＯＮＣＬＵＳＩＯＮ符合英国药典２０００版　ｃｏｍｐｌｉｅｓ　with BP 2000 化验员　Analyst 复核员　Ｃhecker 质保经理　ＱＡ manager // QA director