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

1、检验报告 Certificate of analysis 简称COA分析报告单化工有限公司 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

2、/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

3、& 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

4、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 比旋光度 specific rotation灰分 sulphated ash 水分water content /moisture粒度particles size PH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M

5、icrobial Limit bacteria细菌总数total plate count 霉菌和酵母菌yeast & mold /Mildew&Microzyme大肠杆菌. /Esherichia coli沙门氏菌salmonella 含量纯度 purity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 欧洲药典美国中国. P *.目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