蘇研院
分析中心介紹
蘇州蘇研藥物分析測試科技有限公司（簡稱：中科蘇州藥物研究院分析測試中心），2013年11月18號成立，擁有核磁(NMR)，氣相色譜-質譜聯用檢測儀(GC-MS)、液相色譜-三重四極桿質譜聯用檢測儀(LC-MS)、電感耦合等離子體發(fā)射光譜儀(ICP-OES)、電感耦合等離子體質譜儀(ICP-MS)、高效液相色譜儀(HPLC)、氣相色譜儀(GC)、元素分析儀，離子色譜，全自動溶出儀、微波消解/萃取系統(tǒng)等數十種各種高端檢測儀器設備，并已經通過實驗室計量認證(CMA)。以這些先進的設施設備為基礎，公司目前已經具備了承擔參比制劑逆向剖析、微量雜質分析、藥品包材相容性研究、基因毒性雜質研究，藥學質量研究等檢測分析及研究開發(fā)的技術平臺。
主要研究方向 包括 制劑逆向工程，原輔料剖析，處方工藝開發(fā)，基因毒性雜質研究，包材相容性研究，大型儀器測試。
中心有藥學研究、分析檢測、體系認證領域專家3名，同時還外聘了2名業(yè)內知名教授作為專項技術指導，為中心重點研究項目提供決策依據及技術難題的攻關指導;其他項目經理、技術骨干，負責日常實驗的執(zhí)行、數據報告的核對。一線實驗技術人員均為本科以上學歷，熟悉各項檢測方法、程序。 的專家導師與勤奮刻苦的項目經理組成了中心的中堅力量，加之研究院決策層熟悉整個工作流程，對相關合規(guī)及技術要求有深入的理解，從而保證了承接的各個項目均能完善徹底的執(zhí)行、保質保量的完成。
迄今為止中心團隊已承擔了多個仿制藥委托申報檢測、一致性評價，多個藥品包材相容性研究和食藥等健康領域的檢測服務項目，并與國內產業(yè)界、學術界、政府部門建立了良好的合作關系。
中心目前已經具備了承擔參比制劑逆向剖析、微量雜質分析、藥品包材相容性研究、基因毒性雜質研究，藥學質量研究等檢測分析及研究開發(fā)的技術平臺。
主要研究方向 包括 包材相容性研究，制劑逆向工程，原輔料剖析，處方工藝開發(fā)，基因毒性雜質研究，大型儀器測試。
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.
