药品有关物质检测_检测机构-「中析研究所」

发布：中析研究所时间：2026-10-17 18:34:46访问：162

检测范围

化学原料药有关物质
化药口服固体制剂有关物质
注射用无菌粉末有关物质
大容量注射液有关物质
小容量注射剂有关物质
缓释控释制剂有关物质
中药提取物有关物质
中药复方制剂有关物质
生物制品原液有关物质
重组蛋白类药物有关物质
抗生素类原料药有关物质
头孢类抗生素降解产物
青霉素类聚合物杂质
氨基酸类注射液有关物质
维生素类原料药有关物质
激素类药物有关物质
麻醉药品有关物质
精神类药物有关物质
放射性药品有关物质
疫苗制品宿主细胞蛋白残留
滴眼液有关物质
软膏剂有关物质

检测标准（部分）

GB/T 37876-2019(英文版) 电子电气产品有害物质限制使用符合性评价通则
CEN ISO/TS 19844:2017 Health informatics - Identification of medicinal products - Implementation guidelines for data elements and structures for the unique identification and exchange of regulated information on substances (ISO/TS 19844:2016)
ГОСТ Р ИСО 11238-2014 Информатизация здоровья. Идентификация лекарственных средств. Элементы данных и структуры для уникальной идентификации и обмена информацией о регистрируемых фармацевтических субстанциях
EN ISO 11238:2018 Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated information on substances (ISO 11238:2018)
CEN ISO/TS 19844:2015 Health informatics - Identification of medicinal products - Implementation guidelines for data elements and structures for the unique identification and exchange of regulated information on substances (ISO/TS 19844:2015)
ASTM E2475-23 Standard Guide for Process Understanding Related to Pharmaceutical Manufacture and Control
ASTM E3510-26a Standard Terminology Relating to Trace Materials Analysis
T/CNNDAS 0001-2025 大麻二酚有关物质控制指南
31996R1485 Commission Regulation (EC) No 1485/96 of 26 July 1996 laying down detailed rules for the application of Council Directive 92/109/EEC, as regards customer declarations of specific use relating to certain substances used in the illicit manufacture of narcotic drugs and psychotropic substances (Text with EEA relevance)
BS PD CEN ISO/TS 19844:2017 Health informatics. Identification of medicinal products. Implementation guidelines for data elements and structures for the unique identification and exchange of regulated information on substances
BS EN ISO 11238:2018 Health informatics. Identification of medicinal products. Data elements and structures for the unique identification and exchange of regulated information on substances
T/GDPA 12-2021 多库酯钠含量及有关物质检测
T/GDPA 13-2021 磷酸肌酸钠含量及有关物质检测
UNE 82130:2003 IN Terms and definitions used in connection with reference materials
ISO 11238:2012 Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated information on substances
32000R1533 Commission Regulation (EC) No 1533/2000 of 13 July 2000 amending Regulation (EC) No 1485/96 laying down detailed rules for the application of Council Directive 92/109/EEC, as regards customer declarations of specific use relating to certain substances used in the illicit manufacture of narcotic drugs and psychotropic substances (Text with EEA relevance)
T/GDPA 14-2021 牛磺熊去氧胆酸含量及有关物质检测
T/GDPA 15-2021 猪去氧胆酸甲酯含量及有关物质检测
平成十五年農林水産省令第七十号 医薬品、医療機器等の品質、有効性及び安全性の確保等に関する法律に基づく医薬品及び再生医療等製品の使用の禁止に関する規定の適用を受けない場合を定める省令
32022D0393 Council Decision (EU) 2022/393 of 3 March 2022 on the position to be taken, on behalf of the European Union, in the 65th session of the Commission on Narcotic Drugs as regards the addition of three substances to the list of substances in Table I of the United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances