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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.。
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