氨基葡萄糖盐酸盐COA出厂检验报告单

文件编号XXX版本号XXX股份有限公司XPHARMACEUTICALCO.LTD产品出厂检验报告单CertificateOfAnalysis报告人（QC）/R叩orter核人（QC经理）/Recheckedby:批堆准入（QA经理）/Approver:地址Add:N联系电话TEL:传真Fax□々口口骨D-氨基葡萄糖盐酸盐ProductName:D-GLUCOSAMINEHYDROCHLORIDE生产批号报告日期BatchNo.ReportDate生产日期ManufactureDate数量有效期BatchSize ExpireDate:检验项目Items规格Specification结果ResultsInfraredAbsorption鉴另IJIdentificationChlorideConformedHPLC外观AppearanceAwhitecrystallinepowderConformed比旋度Specificrotation[a]20D+

70.0°—+

73.0°+

72.42°含量Content

98.0%—

102.0%

100.0%硫酸盐Sulfates

0.24%

0.24%干燥失重Lossondrying

0.5%

0.07%炽灼残渣Residueonignition

0.1%

0.08%酸碱度pH

3.5—

5.

04.29氯化物Chloride

16.2%—

16.7%

16.5%堆积密度BulkdensityMeetstherequirements

0.75g/ml拍击密度TappeddensityMeetstherequirements

0.97g/ml目数MeshSizeMeetstherequirements100%through30mesh珅Arsenic3ppm3ppm总细菌数Totalplatecount1000cfu/g20cfu/g霉菌和酵母菌数YeastMold100cfu/g1Ocfu/g大肠杆菌E.COLINegative/gNegative/g沙门氏菌SalmonellaNegative/10gNegative/10g金黄色葡萄球菌StaphylococcusAureusNegative/gNegative/g储仔条件StorageConditionsPreserveintightlight-resistantcontainers.结论ConclusionConformstoUSP39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ICHQ3D元素杂质的限度要求Note AccordingtoICHQ3DtheelementalimpuritiesoftheoralproductwhichtheimpuritiesarenotintentionallyaddedshouldbeconsideredincludingCdPbAsHgCoVNiTheseelementalimpuritiesandanotherelementimpurityCrof3representativeproductionscalelotsoftheproductweretestedbySGSandconsistentlylessthan30%oftheoralconcentrationwhichdemonstrateadditionalcontrolse.g.establishmentofthespecificationlimitsfortheproductarenotrequired.TheelementalimpuritiesoftheproductconformtherequirementofICHQ3D.。