苏州苏研药物分析测试科技有限公司（简称：中科苏州药物研究院分析测试中心），2013年11月18号成立，拥有核磁(NMR)，气相色谱-质谱联用检测仪(GC-MS)、液相色谱-三重四极杆质谱联用检测仪(LC-MS)、电感耦合等离子体发射光谱仪(ICP-OES)、电感耦合等离子体质谱仪(ICP-MS)、高效液相色谱仪(HPLC)、气相色谱仪(GC)、元素分析仪，离子色谱，全自动溶出仪、微波消解/萃取系统等数十种各种高端检测仪器设备，并已经通过实验室计量认证(CMA)。以这些先进的设施设备为基础，公司目前已经具备了承担参比制剂逆向剖析、微量杂质分析、药品包材相容性研究、基因毒性杂质研究，药学质量研究等检测分析及研究开发的技术平台。

　　主要研究方向 包括 制剂逆向工程，原辅料剖析，处方工艺开发，基因毒性杂质研究，包材相容性研究，大型仪器测试。

　　中心有药学研究、分析检测、体系认证领域专家3名，同时还外聘了2名业内知名教授作为专项技术指导，为中心重点研究项目提供决策依据及技术难题的攻关指导;其他项目经理、技术骨干，负责日常实验的执行、数据报告的核对。一线实验技术人员均为本科以上学历，熟悉各项检测方法、程序。 的专家导师与勤奋刻苦的项目经理组成了中心的中坚力量，加之研究院决策层熟悉整个工作流程，对相关合规及技术要求有深入的理解，从而保证了承接的各个项目均能完善彻底的执行、保质保量的完成。

　　迄今为止中心团队已承担了多个仿制药委托申报检测、一致性评价，多个药品包材相容性研究和食药等健康领域的检测服务项目，并与国内产业界、学术界、政府部门建立了良好的合作关系。

　　中心目前已经具备了承担参比制剂逆向剖析、微量杂质分析、药品包材相容性研究、基因毒性杂质研究，药学质量研究等检测分析及研究开发的技术平台。

　　主要研究方向 包括 包材相容性研究，制剂逆向工程，原辅料剖析，处方工艺开发，基因毒性杂质研究，大型仪器测试。

The platform of Suzhou Institute of Pharmaceutical Innovation, Shanghai Institute of Pharmaceutical Innovation, Chinese Academy of Sciences, has nuclear magnetic resonance (NMR), gas chromatography-mass spectrometry (GC-MS), liquid chromatography-triple quadrupole mass spectrometry (LC-MS), inductively coupled plasma emission spectrometry (ICP-OES), inductively coupled plasma mass spectrometry (ICP-MS), high performance liquid chromatography (HPLC), gas chromatography. There are dozens of high-end detection instruments and equipments, such as GC, elemental analyzer, ion chromatography, automatic dissolution instrument, microwave digestion/extraction system, etc., which have passed the National Laboratory Metrology Certification (CMA). Based on these advanced facilities and equipment, the company now has a technical platform to undertake reverse analysis of reference preparations, trace impurities analysis, compatibility study of pharmaceutical packaging materials, genetic toxicity impurities research, pharmaceutical quality research and other detection analysis and research and development.

　　The main research directions include reverse engineering of preparations, analysis of raw materials and accessories, development of prescription technology, study of genotoxic impurities, compatibility of packaging materials, and large-scale instrument testing.

　　The center has three senior experts in pharmaceutical research, analysis and testing, and system certification. At the same time, two well-known professors in the industry are employed as special technical guidance to provide decision-making basis and technical guidance for key research projects. Other project managers and technical backbone are responsible for the implementation of daily experiments and the verification of data reports. Front-line experimental technicians are bachelor degree or above, familiar with various detection methods and procedures. Senior expert tutors and hard-working project managers form the backbone of the center. In addition, the decision-making level of the research institute is familiar with the whole work process and has a deep understanding of the relevant compliance and technical requirements, thus ensuring the complete implementation, quality and quantity of each project undertaken.

　　Up to now, the center team has undertaken a number of generic drug Commission declarations, research and development, consistency evaluation, compatibility research of pharmaceutical packaging and testing services in the health field such as food and medicine, and has established good cooperation with domestic industry, academia and government departments.

　　The center now has a technical platform for testing, analysis and research and development such as reverse analysis of reference preparations, analysis of trace impurities, compatibility studies of pharmaceutical packaging materials, studies of genotoxic impurities, and pharmaceutical quality studies.

　　The main research directions include packaging material compatibility research, formulation reverse engineering, raw material analysis, formulation process development, genotoxic impurities research, and large-scale instrument testing.