氨基葡萄糖盐酸盐COA出厂检验报告单.docx

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1、第1页共1页文件编号：XXX版本号：XXX股份有限公司X PHARMACEUTICAL CO., LTD产品出厂检验报告单(Certificate Of Analysis)口口骨：D-氨基葡萄糖盐酸盐Product Name:D-GLUCOSAMINE HYDROCHLORIDE生产批号：报告日期：Batch No.：Report Date ：生产日期：Manufacture Date ：数量：有效期：Batch Size：Expire Date:检验项目Items规格 Specification结果 ResultsInfrared Absorption鉴另IJIdentificationCh

2、lorideConformedHPLC外观AppearanceA white crystalline powderConformed比旋度Specific rotationa20D+70.0+73.0+72.42含量Content98.0%102.0%100.0%硫酸盐Sulfates0.24%0.24%干燥失重Loss on drying0.5%0.07%炽灼残渣Residue on ignition0.1%0.08%酸碱度pH3.55.04.29氯化物Chloride16.2%16.7%16.5%堆积密度Bulk densityMeets the requirements0.75g/ml拍

3、击密度Tapped densityMeets the requirements0.97g/ml目 数Mesh SizeMeets the requirements100%through 30 mesh珅Arsenic3 ppm3ppm总细菌数Total plate count1000cfu/g20cfu/g霉菌和酵母菌数Yeast&Mold100cfu/g1 Ocfu/g大肠杆菌E.COLINegative/gNegative/g沙门氏菌SalmonellaNegative/10gNegative/10g金黄色葡萄球菌Staphylococcus AureusNegative/gNegativ

4、e/g储仔条件Storage ConditionsPreserve in tight, light-resistant containers.结 论ConclusionConforms to USP39注：按照ICHQ3D的相关要求，针对不是有意添加元素杂质的口服产品应考虑的杂质包括镐Cd、铅Pb、碑As、汞Hg、钻Co、凯V、镣Ni。将连续3批成品批次委托SGS检测这些兀素杂质和铭Cr,低于30%口服浓度限度，可以不用采取额外的措施（如：建立其在产品中的规格限度），产品能够符合ICH Q3D元素杂质的限度要求。Note： According to ICH Q3D, the elemental

5、 impurities of the oral product which the impurities are not intentionally addedshould beconsidered including Cd, Pb, As, Hg, Co, V, Ni,These elemental impurities and another element impurity Cr of 3 representativeproduction scale lots of the product were tested by SGS and consistently less than 30%

6、of the oral concentration, which demonstrateadditional controls (e.g.establishment of the specification limits for the product) are not required.The elemental impurities of theproduct conform the requirement of ICH Q3D.报告人（QC）/R叩orter：核人（QC 经理）/Rechecked by:批堆准入（QA 经理）/ Approver:地址：Add:N联系电话： TEL: 传真：Fax：