机构名称：北京同仁堂健康药业股份有限公司研发中心

机构名称：北京同仁堂健康药业股份有限公司研发中心 ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1 机构名称:北京同仁堂健康药业股份有限公司研发中心 注册号:L4674 地 址: A:北京市海淀区上地信息路2号国际创业园C栋3层 获准认可能力索引 序号 地址 能力范围 评审类型 更新时间 1 授权签字人(中文) 复评+扩项 2013年07月22日 2 授权签字人(英文) 复评+扩项 2013年07月22日 A 3 授权签字人(中文) 监督 2014年11月05日 4 授权签字人(英文) 监督 2014年11月05日 5 检测能力(中文) 复评+扩项 2013年07月22日 6 检测能力(英文) 复评+扩项 2013年07月22日 A 7 检测能力(中文) 监督 2014年11月05日 8 检测能力(英文) 监督 2014年11月05日 No. CNAS L4674 第 1 页 共 35 页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1 Name:Beijing Tongrentang Health Pharmaceutical Co., Ltd. R&D Center Registration No.:L4674 ADDRESS: A: 3/F., Tower C, International Science & Technology Park, No.2, Shangdi Xinxi Road, Haidian District, Beijing, China INDEX OF ACCREDITED SIGNATORIES No. Address Range Type Update date Reassessment 1 Approved signatories (Chinese) +Extending 2013-07-22 assessment Reassessment A 2 Approved signatories (English) +Extending 2013-07-22 assessment 3 Approved signatories (Chinese) Surveillance 2014-11-05 4 Approved signatories (English) Surveillance 2014-11-05 Reassessment 5 Testing ability(Chinese) +Extending 2013-07-22 assessment Reassessment A 6 Testing ability(English) +Extending 2013-07-22 assessment 7 Testing ability(Chinese) Surveillance 2014-11-05 8 Testing ability(English) Surveillance 2014-11-05 No. CNAS L4674 第 2 页 共 35 页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1 中国合格评定国家认可委员会 认 可 证 书 附 件 (注册号:CNAS L4674) 名称: 北京同仁堂健康药业股份有限公司研发中心 地址:北京市海淀区上地信息路2号国际创业园C栋3层 签发日期:2013年07月22日 有效期至:2016年07月21日 更新日期:2013年07月22日 附件1 认可的授权签字人及领域 序号 姓 名 授权签字领域 备 注 1 张宏 全部检测项目 2 查圣华 全部检测项目 3 姜水红 全部检测项目 No. CNAS L4674 第 3 页 共 35 页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1 CHINA NATIONAL ACCREDITATION SERVICE FOR CONFORMITY ASSESSMENT APPENDIX OF ACCREDITATION CERTIFICATE (Registration No. CNAS L4674) NAME:Beijing Tongrentang Health Pharmaceutical Co., Ltd. R&D Center ADDRESS:3/F., Tower C, International Science & Technology Park, No.2, Shangdi Xinxi Road, Haidian District, Beijing, China Date of Issue:2013-07-22 Date of Expiry:2016-07-21 Date of Update:2013-07-22 APPENDIX 1 ACCREDITED SIGNATORIES AND SCOPE ? Name Authorized Scope of Signature Note 1 Hong Zhang Accredited Items on All Testing 2 Shenghua Zha Accredited Items on All Testing 3 Shuihong Jiang Accredited Items on All Testing No. CNAS L4674 第 4 页 共 35 页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1 中国合格评定国家认可委员会 认 可 证 书 附 件 (注册号:CNAS L4674) 名称: 北京同仁堂健康药业股份有限公司研发中心 地址:北京市海淀区上地信息路2号国际创业园C栋3层 认可依据:ISO/IEC 17025:2005以及CNAS特定认可要求 签发日期:2013年07月22日 有效期至:2016年07月21日 更新日期:2013年07月22日 附件2 认可的检测能力范围 项目/参数 序检测 领域 检测标准(方法)名称限制 说明 号 对象 代码 及编号(含年号) 范围 序号 名称 中国药典2010年版 一 部附录? 0101.0 (一般鉴别) 1 药品 1 鉴别 9/0101 中国药典2010年版 .12 一部附录 VIB (薄层色谱法) No. CNAS L4674 第 5 页 共 35 页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1 项目/参数 序检测 领域 检测标准(方法)名称限制 说明 号 对象 代码 及编号(含年号) 范围 序号 名称 中国药典2010年版 一 部附录V A(紫外-可见分光光 0101.0 度法) 2 含量测定 9/0101 中国药典2010年版 一 .12 部附录? D(高效液相色谱 法) 0101.0中国药典2010年版 二只用第3 相对密度 9/0101部附录? A 一法 .12 一部附录? A pH值(酸0101.0中国药典2010年版 4 度、碱度、9/0101一部附录? G 酸碱度) .12 0101.0中国药典2010年版 二 5 干燥失重 9/0101部附录? L .12 一部附录? G 1 药品 0101.0中国药典2010年版 一部不用第6 水分 9/0101附录? H 四法 .12 0101.0中国药典2010年版 7 炽灼残渣 9/0101二部附录? N .12 一部附录? J 0101.0中国药典2010年版 一部 8 崩解时限 9/0101附录? A .12 0101.0中国药典2010年版 一部 9 最低装量 9/0101附录? C .12 0101.0 中国药典2010年版 一部 10 杂质 9/0101 附录? A .12 No. CNAS L4674 第 6 页 共 35 页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1 项目/参数 序检测 领域 检测标准(方法)名称限制 说明 号 对象 代码 及编号(含年号) 范围 序号 名称 0101.0中国药典2010 铅、镉、砷、只用第 11 9/0101一部附录? B(原子吸收分光汞、铜 一法 .12 光度法) 0101.0中国药典2010年版 12 灰分 9/0101一部附录? K .12 0101.0中国药典2010年版 13 浸出物 9/0101一部附录X A .12 1 药品 0101.0中国药典2010年版 一 14 性状 9/0101部 .12 0101.0中国药典2010年版 二 15 溶解度 9/0101部凡例 .12 一部凡例 重量差异0101.0中国药典2010年版 16 (装量差9/0101一部附录I 异) .12 0226.2食品中水分的测定 GB 1 水分 4 5009.3-2010 0226.2食品中灰分的测定 GB 2 灰分 4 5009.4-2010 0226.2食品中蛋白质的测定GB 只用第 3 蛋白质 食品/保健1 5009.5-2010 一法 2 食品 罐头食品的检验方法 0226.2GB/T10786-2006 饮用天 4 pH值 4 然矿泉水检验方法 GB/T8538-2008 0226.2水产品中盐分的测定 5 盐分 4 SC/T3011-2001 No. CNAS L4674 第 7 页 共 35 页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1 项目/参数 序检测 领域 检测标准(方法)名称限制 说明 号 对象 代码 及编号(含年号) 范围 序号 名称 0227.0食品中铁、镁、锰的测定 6 铁 9 GB/T5009.90-2003 0227.0食品中铁、镁、锰的测定 7 镁 9 GB/T5009.90-2003 0227.0食品中铁、镁、锰的测定 8 锰 9 GB/T5009.90-2003 0227.0食品中铅的测定 GB 只用第9 铅 9 5009.12-2010 一法 0227.0食品中铜的测定 10 铜 9 GB/T5009.13-2003 0227.0食品中锌的测定11 锌 9 GB/T5009.14-2003 0227.0食品中总汞及有机汞的测定 只用第12 汞 9 GB/T5009.17-2003 一法 食品/保健0227.0食品中锡的测定2 13 锡 食品 9 GB/T5009.16-2003 0227.0食品中硒的测定 14 硒 9 GB 5009.93-2010 0227.0食品中总砷及无机砷的测定 只用第15 砷 9 GB/T5009.11-2003 一法 0227.0食品中钙的测定16 钙 9 GB/T5009.92-2003 0227.0食品中镉的测定 17 镉 9 GB/T5009.15-2003 保健食品功效成分检测方法 只用分0226.2 18 粗多糖 2002年版 粗多光光度1 糖的测定方法 法 保健食品检验与评价技术规 0226.2 19 总皂苷 范 2003年版 1 保健食品中总皂苷的测定 No. CNAS L4674 第 8 页 共 35 页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1 项目/参数 序检测 领域 检测标准(方法)名称限制 说明 号 对象 代码 及编号(含年号) 范围 序号 名称 保健食品检验与评价技术规0226.2 20 总黄酮 范 2003年版 1 保健食品中总黄酮的测定 保健食品检验与评价技术规0226.2 21 原花青素 范 2003年版 1 保健食品中原花青素的测定 保健食品功效成分检测方法 0226.2 22 总蒽醌 2011年版 总蒽1 醌的分光光度测定法 0226.2食用葡萄糖 23 葡萄糖含量 1 GB/T 20880-2007 0226.0食品中钾、钠的测定GB/T 24 钠 9 5009.91-2003 0226.2食品中蔗糖的测定 食品/保健25 蔗糖 2 1 GB/T 5009.8-2008 食品 0226.2食品中脂肪的测定 26 脂肪 1 GB/T 5009.6-2003 可溶性固形0226.2饮料通用分析方法 只用折27 物 1 GB/T 12143-2008 光计法 0226.2食品中氯化钠的测定 只用附28 氯化钠 1 GB/T 12457-2008 录A 食品中亚硝酸盐与硝酸盐的0226.2只用第29 亚硝酸盐 测定 1 二法 GB 5009.33-2010 0226.2唾液酸的测定方法 30 唾液酸 1 Q/TJP 003-2010 肽分子量分0226.2海洋鱼低聚肽粉 只用附31 布 1 GB/T 22729-2008 录A No. CNAS L4674 第 9 页 共 35 页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1 项目/参数 序检测 领域 检测标准(方法)名称限制 说明 号 对象 代码 及编号(含年号) 范围 序号 名称 茶叶中茶多酚和儿茶素类含0226.2 32 茶多酚 量的检测方法 1 GB/T 8313-2008 0227.0食品中铬的测定 GB/T 只用第 33 铬 9 5009.123-2003 一法 食品/保健 2 0226.2中国药典2010年版 一部食品 34 崩解时限 1 附录? A 重量差异 0226.2中国药典2010年版 35 (装量差 1 一部附录I 异) No. CNAS L4674 第 10 页 共 35 页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/3 CHINA NATIONAL ACCREDITATION SERVICE FOR CONFORMITY ASSESSMENT APPENDIX OF ACCREDITATION CERTIFICATE (Registration No. CNAS L4674) NAME:Beijing Tongrentang Health Pharmaceutical Co., Ltd. R&D Center ADDRESS:3/F., Tower C, International Science & Technology Park, No.2, Shangdi Xinxi Road, Haidian District, Beijing, China Accreditation Criteria:ISO/IEC 17025:2005 and relevant requirements of CNAS Date of Issue:2013-07-22 Date of Expiry:2016-07-21 Date of Update:2013-07-22 APPENDIX 2 ACCREDITED TESTING Item/Parameter Code of Title, Code of Test Object Limitation Note ? Item/ Field Standard or Method ? Parameter ChP2010 Vol ? Appendix ? (Indentification ) Indentificati0101.09/1 Medicines 1 ChP2010 Vol ? on 0101.12 Appendix VIB (Thin-layer Chromatography) No. CNAS L4674 第 11 页 共 35 页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/3 Item/Parameter Code of Title, Code of Test Object Limitation Note ? Item/ Field Standard or Method ? Parameter ChP2010 Vol.? Appendix VA(Spectrophotome try and 0101.09/Light-Scattering) 2 assay 0101.12 ChP2010Vol.? Appendix? D(High Performance Liquid ChP2010 DeterminatiAccrediated Vol.?Appendix? on of 0101.09/3 only for the A Vol.?Relative 0101.12 first method Density Appendix? A ChP2010 Determinati0101.09/4 on of pH Vol.?Appendix? 0101.12 Value G 1 Medicines ChP2010 DeterminatiVol.?Appendix? 0101.09/5 on of Loss 0101.12 L Vol.?on Drying Appendix? G ChP2010 Determinati0101.09/Except for the 6 Vol.?Appendix? on of Water 0101.12 forth method H ChP2010 Determinati Vol.?Appendix? on of 0101.09/7 N Vol.?Residue on 0101.12 Ignition Appendix? J DeterminatiChP2010 on of 0101.09/Vol.?Appendix? 8 Disintegrati0101.12 A on No. CNAS L4674 第 12 页 共 35 页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/3 Item/Parameter Code of Title, Code of Test Object Limitation Note ? Item/ Field Standard or Method ? Parameter ChP2010 Minimum 0101.09/9 Vol.?Appendix? Fill 0101.12 C DeterminatiChP2010 on of 0101.09/10 Vol.?Appendix? Foreign 0101.12 A Matter DeterminatiChP2010 on of Vol.?Appendix? Accrediated 0101.09/lead,cadmiu11 only for the B(Atomic 0101.12 m,arsenic, first method Absorption mercury, Spectrophoto-metry) copper ChP2010 1 Medicines Determinati0101.09/12 Vol.?Appendix? on of Ash 0101.12 K DeterminatiChP2010 0101.09/13 on of 0101.12 Vol.?AppendixX A Extractives 0101.09/14 Description ChP2010 Vol.? 0101.12 ChP20010 Vol.?General 0101.09/15 Solubility 0101.12 notices Vol.? General notices ChP2010 Weight 0101.09/16 variation 0101.12 Vol.?Appendix I Determination of Foods/ Health Determinatimoisture content in 2 1 0226.24 Foods on of Water food GB 5009.3-2010 No. CNAS L4674 第 13 页 共 35 页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/3 Item/Parameter Code of Title, Code of Test Object Limitation Note ? Item/ Field Standard or Method ? Parameter Determination of Determinati2 0226.24 ash content in food on of Ash GB 5009.4-2010 Determination of Accrediated protein content in 3 Protein 0226.21 only for the food first method GB 5009.5-2010 Testting methods for Canned food GB/T 10786-2006 DeterminatiMethods for 4 on of pH 0226.24 examination of Value drinking natural mineral water GB/T 8538-2008 Foods/ Health Determination of 2 Foods salt in aquatic 5 Salt 0226.24 products SC/T3011-2001 Determination of iron, magnesium and 6 iron 0227.09 manganese in foods GB/T5009.90-2003 Determination of iron, magnesium and 7 magnesium 0227.09 manganese in foods GB/T5009.90-2003 Determination of iron, magnesium and 8 manganese 0227.09 manganese in foods GB/T5009.90-2003 No. CNAS L4674 第 14 页 共 35 页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/3 Item/Parameter Code of Title, Code of Test Object Limitation Note ? Item/ Field Standard or Method ? Parameter Determination of Accrediated 9 lead 0227.09 lead in foods only for the GB 5009.12-2010 first method Determination of 10 copper 0227.09 copper in foods GB/T5009.13-2003 Determination of 11 zinc 0227.09 zinc in foods GB/T5009.14-2003 Determination of Accrediated total mercury in 12 mercury 0227.09 only for the foods first method GB/T5009.17-2003 Foods/ Health Determination of Sn 2 Foods 13 Sn 0227.09 mercury in foods GB/T5009.16-2003 Determination of 14 selenium 0227.09 selenium in foods GB 5009.93-2010 Determination of Accrediated 15 arsenic 0227.09 total arsenic in foods only for the GB/T5009.11-2003 first method Determination of Ca 16 Ca 0227.09 in foods GB/T5009.92-2003 Determination of Cd 17 Cd 0227.09 in foods GB/T5009.15-2003 No. CNAS L4674 第 15 页 共 35 页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/3 Item/Parameter Code of Title, Code of Test Object Limitation Note ? Item/ Field Standard or Method ? Parameter Methods for Accredited detection Polysaccharonly for effectiveness of 18 0226.21 ide Spectrophotohealth foods 2002 Determination of metry polysaccharide Technical Standards for Testing & Total Assessment of 19 Ginsenoside0226.21 Health Foods 2003 s Determination of total ginsenosides in health foods Foods/ Health Technical Standards 2 Foods for Testing & Assessment of Total 20 0226.21 Health Foods 2003 Flavonoids Determination of total flavonoids in health foods Technical Standards for Testing & Assessment of ProcyanidinHealth Foods 2003 21 0226.21 s Determination of procyanidins in health foods BJGF 0274-2003 No. CNAS L4674 第 16 页 共 35 页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/3 Item/Parameter Code of Title, Code of Test Object Limitation Note ? Item/ Field Standard or Method ? Parameter Methods for detection Total effectiveness of Anthraquin22 0226.21 health foods 2011 ones Total anthraquinone spectrophotometry Consumption of 23 Glucose 0226.21 glucose GB/T 20880-2007 Determination of potassium and 24 Sodium 0226.21 sodium in foods GB/T 5009.91-2003 Determination of 25 Sucrose 0226.21 sugar in foods Foods/ Health 2 GB/T 5009.8-2008 Foods Determination of fat 26 Fat 0226.21 in foods GB/T 5009.6-2003 Accredited General analysis of Soluble only for 27 0226.21 beverages solids Refractive GB/T 12143-2008 method Determination of Sodium Accredited sodium chloride in 28 chloride 0226.21 only for foods appendix A GB/T 12457-2008 Determination of Accredited nitrite and nitrate in only for the 29 Nitrite 0226.21 foods second GB 5009.33-2010 method No. CNAS L4674 第 17 页 共 35 页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/3 Item/Parameter Code of Title, Code of Test Object Limitation Note ? Item/ Field Standard or Method ? Parameter Determination of 30 Sialic acid 0226.21 sialic acid Q/TJP 003-2010 Peptide Oligopeptide Accredited molecular powder 31 0226.21 only for weight of marine fish appendix A distribution GB/T 22729-2008 Determination of total polyphenols Tea 32 0226.21 and catechins polyphenols content in tea Foods/ Health 2 GB/T 8313-2008 Foods Determination of Accredited chromium in foods 33 Cr 0227.09 only for the GB/T first method 5009.123-2003 DeterminatiChP2010 on of Vol.?Appendix? 34 0226.21 Disintegrati A on ChP2010 Weight 35 0226.21 Vol.?Appendix I variation No. CNAS L4674 第 18 页 共 35 页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/3 中国合格评定国家认可委员会 认 可 证 书 附 件 (注册号:CNAS L4674) 名称:北京同仁堂健康药业股份有限公司研发中心 地址:北京市海淀区上地信息路2号国际创业园C栋3层 签发日期:2013年07月22日 有效期至:2016年07月21日 更新日期:2014年11月05日 附件1 认可的授权签字人及领域 序号 姓 名 授权签字领域 备 注 1 张宏 药品、食品、保健食品检测项目 2 查圣华 药品、食品、保健食品检测项目 3 姜水红 药品、食品、保健食品检测项目 No. CNAS L4674 第 19 页 共 35 页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/3 CHINA NATIONAL ACCREDITATION SERVICE FOR CONFORMITY ASSESSMENT APPENDIX OF ACCREDITATION CERTIFICATE (Registration No. CNAS L4674) NAME:Beijing Tongrentang Health Pharmaceutical Co., Ltd. R&D Center ADDRESS:3/F., Tower C, International Science & Technology Park, No.2, Shangdi Xinxi Road, Haidian District, Beijing, China Date of Issue:2013-07-22 Date of Expiry:2016-07-21 Date of Update:2014-11-05 APPENDIX 1 ACCREDITED SIGNATORIES AND SCOPE ? Name Authorized Scope of Signature Note 1 Hong Zhang Drugs、foods、Health foods 2 Shenghua Zha Drugs、foods、Health foods 3 Shuihong Jiang Drugs、foods、Health foods No. CNAS L4674 第 20 页 共 35 页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/3 中国合格评定国家认可委员会 认 可 证 书 附 件 (注册号:CNAS L4674) 名称:北京同仁堂健康药业股份有限公司研发中心 地址:北京市海淀区上地信息路2号国际创业园C栋3层 认可依据:ISO/IEC 17025以及CNAS特定认可要求 签发日期:2013年07月22日 有效期至:2016年07月21日 更新日期:2014年11月05日 附件2 认可的检测能力范围 项目/参数 序检测 检测标准(方法)名称限制 说明 号 对象 及编号(含年号) 范围 序号 名称 中国药典2010年版 一 部附录? (一般鉴别) 1 药品 1 鉴别 中国药典2010年版 一部附录 VIB (薄层色谱法) No. CNAS L4674 第 21 页 共 35 页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/3 项目/参数 序检测 检测标准(方法)名称限制 说明 号 对象 及编号(含年号) 范围 序号 名称 中国药典2010年版 一 部附录V A(紫外-可见分光光 度法) 2 含量测定 中国药典2010年版 一 部附录? D(高效液相色谱 法) 中国药典2010年版 二只用第 3 相对密度 部附录? A 一法 一部附录? A pH值(酸中国药典2010年版 4 度、碱度、一部附录? G 酸碱度) 中国药典2010年版 二1 药品 5 干燥失重 部附录? L 一部附录? G 中国药典2010年版 一部不用第 6 水分 附录? H 四法 中国药典2010年版 7 炽灼残渣 二部附录? N 一部附录? J 中国药典2010年版 一部 8 崩解时限 附录? A 中国药典2010年版 一部9 最低装量 附录? C 中国药典2010年版 一部10 杂质 附录? A 中国药典2010 铅、镉、砷、只用第 1 药品 11 一部附录? B(原子吸收分光汞、铜 一法 光度法) No. CNAS L4674 第 22 页 共 35 页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/3 项目/参数 序检测 检测标准(方法)名称限制 说明 号 对象 及编号(含年号) 范围 序号 名称 中国药典2010年版 12 灰分 一部附录? K 中国药典2010年版 13 浸出物 一部附录X A 中国药典2010年版 一 14 性状 部 1 药品 中国药典2010年版 二 15 溶解度 部凡例 一部凡例 重量差异中国药典2010年版 16 (装量差一部附录I 异) 食品安全国家标准 食品中不用第1 水分 水分的测定 GB 四法 5009.3-2010 食品安全国家标准 食品 2 灰分 中灰分的测定 GB 5009.4-2010 食品安全国家标准 食品中只用第3 蛋白质 蛋白质的测定 GB 一法 5009.5-2010 2 食品 罐头食品的检验方法 GB/T10786-2006 饮用天 4 pH值 然矿泉水检验方法 GB/T8538-2008 只用直水产品中盐分的测定 5 盐分 接滴定SC/T3011-2001 法 食品中铁、镁、锰的测定 6 铁 GB/T5009.90-2003 No. CNAS L4674 第 23 页 共 35 页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/3 项目/参数 序检测 检测标准(方法)名称限制 说明 号 对象 及编号(含年号) 范围 序号 名称 食品中铁、镁、锰的测定 7 镁 GB/T5009.90-2003 食品中铁、镁、锰的测定 8 锰 GB/T5009.90-2004 2 食品 食品安全国家标准 食品只用第9 铅 中铅的测定 一法 GB5009.12-2010 食品中铜的测定 只用第10 铜 GB/T5009.13-2003 一法 食品中锌的测定只用第11 锌 GB/T5009.14-2003 一法 食品中总汞及有机汞的测定 只用第12 总汞 GB/T5009.17-2003 一法 食品中锡的测定只用第13 锡 GB/T5009.16-2003 一法 食品安全国家标准 食品中只用第14 硒 硒的测定 一法 GB 5009.93-2010 食品中总砷及无机砷的测定 只用第15 (总)砷 GB/T5009.11-2003 一法 2 食品 只用原 食品中钙的测定子吸收16 钙 GB/T5009.92-2003 分光光 度法 食品中镉的测定只用第17 镉 GB/T5009.15-2003 一法 食品中钾、钠的测定GB/T 18 钠 5009.91-2003 食品中蔗糖的测定 只用第19 蔗糖 GB/T 5009.8-2008 一法 No. CNAS L4674 第 24 页 共 35 页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/3 项目/参数 序检测 检测标准(方法)名称限制 说明 号 对象 及编号(含年号) 范围 序号 名称 食品中脂肪的测定 20 脂肪 GB/T 5009.6-2003 食品中氯化钠的测定 只用附21 氯化钠 GB/T 12457-2008 录A 食品中亚硝酸盐与硝酸盐的只用第 2 食品 22 亚硝酸盐 测定 二法 GB 5009.33-2010 可溶性固形饮料通用分析方法 只用折23 物 GB/T 12143-2008 光计法 食品中铬的测定 GB/T 只用第24 铬 5009.123-2003 一法 食用葡萄糖 2 食品 25 葡萄糖含量 GB/T 20880-2007 保健食品功效成分检测方法 只用分 1 粗多糖 2002年版 粗多光光度 糖的测定方法 法 保健食品检验与评价技术规 2 总皂苷 范 2003年版 保健食品中总皂苷的测定 保健食品检验与评价技术规 3 总黄酮 范 2003年版 3 保健食品 保健食品中总黄酮的测定 保健食品检验与评价技术规 4 原花青素 范 2003年版 保健食品中原花青素的测定 保健食品功效成分检测方法 5 总蒽醌 2011年版 总蒽 醌的分光光度测定法 唾液酸的测定方法 6 唾液酸 Q/TJP 003-2010 No. CNAS L4674 第 25 页 共 35 页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/3 项目/参数 序检测 检测标准(方法)名称限制 说明 号 对象 及编号(含年号) 范围 序号 名称 肽分子量分海洋鱼低聚肽粉 只用附 7 布 GB/T 22729-2008 录A 茶叶中茶多酚和儿茶素类含 8 茶多酚 量的检测方法 GB/T 8313-2008 3 保健食品 中国药典2010年版 一部 9 崩解时限 附录? A 重量差异 中国药典2010年版 10 (装量差 一部附录I 异) No. CNAS L4674 第 26 页 共 35 页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1 CHINA NATIONAL ACCREDITATION SERVICE FOR CONFORMITY ASSESSMENT APPENDIX OF ACCREDITATION CERTIFICATE (Registration No. CNAS L4674) NAME:Beijing Tongrentang Health Pharmaceutical Co., Ltd. R&D Center ADDRESS:3/F., Tower C, International Science & Technology Park, No.2, Shangdi Xinxi Road, Haidian District, Beijing, China Accreditation Criteria:ISO/IEC 17025 and relevant requirements of CNAS Date of Issue:2013-07-22 Date of Expiry:2016-07-21 Date of Update:2014-11-05 APPENDIX 2 ACCREDITED TESTING Item/Parameter Title, Code of Test Object Limitation Note ? Item/ Standard or Method ? Parameter ChP2010 Vol ? Appendix ? (Indentification ) Indentificati1 Medicines 1 ChP2010 Vol ? on Appendix VIB (Thin-layer Chromatography) No. CNAS L4674 第 27 页 共 35 页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1 Item/Parameter Title, Code of Test Object Limitation Note ? Item/ Standard or Method ? Parameter ChP2010 Vol.? Appendix VA(Spectrophotome try and Light-Scattering) 2 assay ChP2010Vol.? Appendix? D(High Performance Liquid ChP2010 Accrediated Vol.?Appendix? Relative 3 only for the A Vol.?Density first method Appendix? A ChP2010 4 pH Value Vol.?Appendix? 1 Medicines G ChP2010 Vol.?Appendix? Loss on 5 L Vol.?Drying Appendix? G ChP2010 Except for the 6 Water Vol.?Appendix? forth method H ChP2010 Vol.?Appendix? Residue on 7 Ignition N Vol.? Appendix? J ChP2010 Disintegrati8 Vol.?Appendix? on A No. CNAS L4674 第 28 页 共 35 页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1 Item/Parameter Title, Code of Test Object Limitation Note ? Item/ Standard or Method ? Parameter ChP2010 Minimum 1 Medicines 9 Vol.?Appendix? Fill C ChP2010 Foreign 10 Vol.?Appendix? Matter A ChP2010 lead,cadmiuAccrediated Vol.?Appendix? m,arsenic, 11 only for the B(Atomic mercury, first method Absorption copper Spectrophoto-metry) ChP2010 12 Ash Vol.?Appendix? 1 Medicines K ChP2010 13 Extractives Vol.?AppendixX A ChP2010 Vol.? 14 Description ChP20010 Vol.?General 15 Solubility notices Vol.? General notices ChP2010 Weight 16 variation Vol.?Appendix I National food safty standard Except for the Determination of 2 Foods 1 moistrue forth method moisture content in food GB 5009.3-2010 No. CNAS L4674 第 29 页 共 35 页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1 Item/Parameter Title, Code of Test Object Limitation Note ? Item/ Standard or Method ? Parameter National food safty standard 2 Ash Determination of ash content in food GB 5009.4-2010 National food safty standard Accrediated Determination of 3 Protein only for the protein content in 2 Foods first method food GB 5009.5-2010 Testting methods for Canned food GB/T 10786-2006 4 pH examination of drinking natural mineral water GB/T 8538-2008 Determination of Accrediated salt in aquatic only for direct 5 Salt products titration SC/T3011-2001 method Determination of iron, magnesium and 6 iron manganese in foods GB/T5009.90-2003 2 Foods Determination of iron, magnesium and 7 magnesium manganese in foods GB/T5009.90-2003 Determination of iron, magnesium and 8 manganese manganese in foods GB/T5009.90-2003 No. CNAS L4674 第 30 页 共 35 页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1 Item/Parameter Title, Code of Test Object Limitation Note ? Item/ Standard or Method ? Parameter National food safty standard Accrediated 9 lead Determination of only for the lead in foods first method GB 5009.12-2010 Determination of Accrediated 10 copper copper in foods only for the GB/T5009.13-2003 first method Determination of Accrediated 11 zinc zinc in foods only for the GB/T5009.14-2003 first method Determination of Accrediated total total mercury in 2 Foods 12 only for the mercury foods first method GB/T5009.17-2003 Determination of tin Accrediated 13 Tin in foods only for the GB/T5009.16-2003 first method National food Accrediated safty standard 14 selenium only for the Determination of first method selenium in foods GB 5009.93-2010 Determination of Accrediated 15 total arsenic total arsenic in foods only for the GB/T5009.11-2003 first method Accrediated only for Determination of Atomic 2 Foods 16 Calcium calcium in foods absorption GB/T5009.92-2003 spectrophoto metry No. CNAS L4674 第 31 页 共 35 页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1 Item/Parameter Title, Code of Test Object Limitation Note ? Item/ Standard or Method ? Parameter Determination of Accrediated 17 Cadmium cadmium in foods only for the GB/T5009.15-2003 first method Determination of potassium and 18 Sodium sodium in foods GB/T 5009.91-2003 Determination of Accrediated 19 Sucrose sugar in foods only for the GB/T 5009.8-2008 first method Determination of fat 20 Fat in foods GB/T 5009.6-2003 Determination of Sodium Accredited sodium chloride in 21 chloride only for 2 Foods foods appendix A GB/T 12457-2008 National food Accredited safty standard only for the Determination of 22 Nitrite second nitrite and nitrate in foods method GB 5009.33-2010 Accredited General analysis of Soluble only for 23 beverages solids Refractive GB/T 12143-2008 method Determination of Accredited chromium in foods 24 chromium only for the GB/T first method 5009.123-2003 No. CNAS L4674 第 32 页 共 35 页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1 Item/Parameter Title, Code of Test Object Limitation Note ? Item/ Standard or Method ? Parameter Consumption of 2 Foods 25 Glucose glucose GB/T 20880-2007 Methods for detection Accredited effectiveness of Polysaccharonly for 1 health foods ide Spectrophoto(Edition 2002) metry Determination of polysaccharide Technical Standards for Testing & Assessment of Total Health Foods 2 Ginsenoside (Edition 2003) s Determination of total ginsenosides in health foods 3 Health Foods Technical Standards for Testing & Assessment of Total Health Foods 3 Flavonoids (Edition 2003) Determination of total flavonoids in health foods Technical Standards for Testing & Assessment of ProcyanidinHealth Foods 4 s (Edition 2003) Determination of procyanidins in health foods No. CNAS L4674 第 33 页 共 35 页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1 Item/Parameter Title, Code of Test Object Limitation Note ? Item/ Standard or Method ? Parameter Methods for detection Total effectiveness of Anthraquinhealth foods 5 ones ( Edition 2011 ) Total anthraquinone spectrophotometry Determination of 6 Sialic acid sialic acid 3 Health Foods Q/TJP 003-2010 Peptide Oligopeptide Accredited molecular powder 7 only for weight of marine fish appendix A distribution GB/T 22729-2008 Determination of total polyphenols Tea 8 and catechins polyphenols content in tea GB/T 8313-2008 ChP2010 Disintegrati9 Vol.?Appendix? on A 3 Health Foods ChP2010 Weight 10 Vol.?Appendix I variation No. CNAS L4674 第 34 页 共 35 页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only. ISO/IEC 17025 认可证书 CNAS-PD20/09-B/1 No. CNAS L4674 第 35 页 共 35 页 Should there be any inconsistencies between Chinese and English versions of the scope of accreditation, the Chinese version shall prevail in that the English version is provided by the conformity assessment body and is for reference only.