certificate of analysis质量分析报告

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1、安康市禾烨生物工程有限公司AnkangHEYEBio-EngineeringCo.LtdCertificateofAnalysis质量分析报告ProductName（产品名称）PuerariaeP.E葛根提取物ManufactureDate（生产日期）2006/02/21BatchNumber（生产批号）T60221-IReportDate（报告日期）2006/02/26BatchQuantity（批号数量）931.7SamplingDate（取样日期）2006/02/23LatinName（拉丁名）GeGenHuangTongExpirationDate（失效日期）200

2、6/02/20TypeofProducts（产品类型）P.EActiveIngredientMarkers（活性成分）Puerarin，DDG，MOP，Daidzin，DaidzeinItem检验项目Specificatlon标准Results结果Methods检验方法MarkerCompounda指标成分含量RadixPuerarinFlova葛根异黄酮40%44.187%WS1-（X-62）-2000ZOrganolepticData性状检查Appearance&Color外表颜色Powder&Lightyellow淡黄色或浅黄色精细粉末Conform符合规定WS1-（

3、X-62）-2000ZOdor&Taste气味滋味Characteristic特殊气味ConformWS1-（X-62）-2000ZProcessData工艺数据PlantPartUsed药用部位Root根Conform符合规定ExtractSolvent所用溶剂Water&EthanolConform符合规定MethodofExtraction提取方法SoakandcarryConform符合规定DryingMethod干燥方法Excipient赋形剂Negative无ConformPhysicalCharacteristics物理性状MeshSize目数100-1201

4、00%GB5507-85Solubility(water)水溶性DissolvealittleConformGB5492-85No.220JiangbeizhoutaiAnkangshannxi725000china陕西省安康市江北周台220号725000Tel:0086-915-3311019Fax:0086-915-3312492Http://www.95hy.comEmail:heyeshengwu@163.com安康市禾烨生物工程有限公司AnkangHEYEBio-EngineeringCo.LtdLossonDrying干燥失重≤5.0%3.9%GB5492-85

5、AshContent总灰分≤5.0%2.0%AOAC942.05,17thSolventResidue溶剂残留Negative无ConformHeavyMetals重金属检查TotalHeavyMetals重金属总量≤10mg/KgConformArsenic(As)砷≤0.5mg/Kg0.25474AOAC985.01,16thCadmium(Cd)镉≤1mg/Kg0.0473GB/T5009.15-1996Lead(Pb)铅≤2mg/Kg0.08AOAC985.01,16thMierobiology汞≤0.5mg/KgConformAOAC971.21/977.15Su

6、lphate（硫化物）Negative无ConformPhosphateOrganics有机磷Negative无ConformOrganicsResidues有机残留Negative无ConformPesticidesResidues杀虫剂残留Negative无ConformMierobiology微生物检查TotalPlateCount菌落总数≤500cfu/gConformAOAC990.12,16thTotalYeast&Mold酵母菌与霉菌≤100cfu/gConformFDA(BAM)Chapter18,8thEdE.Coli大肠杆菌Negative无Confor

7、mAOAC97555,16thSalmonella沙门氏菌Negative无ConformFDA(BAM)Chapter5,8thEdStaphylococcus葡萄球菌Negative无PackingandStorage包装与储存Inside:Double-deckplasticbag,outside:Neutralcardboardbarrel&LeaveintheshadyandcooldryplaceShelfLife货架时间2YearWhenStoredproperlyExpirationDate保质期3