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The Analytical Testing Center can provide testing technical services to domestic and foreign pharmaceutical enterprises, and has accumulated rich experience in drug quality research, mainly providing research and testing services that meet the requirements of NMPA, FDA, EMA and other regulations, such as the analysis of trace substances, genotoxic impurities, element impurities, residual solvents, polymer impurities, complex preparation excipients, as well as drug contact system compatibility research. The Center has successively passed the ISO9001 Quality Management System Certification and the Laboratory Accreditation Qualification of China National Accreditation Service for Conformity Assessment(CNAS）
Platform overview
The center has a professional laboratory of 2000㎡, a highly specialized R&D technical team, rich experience in detection technology and drug R&D, and nearly 100 employees, including 5 doctors, over 80% of members have a Master degree or above. It is equipped with more than 50 high-end instruments and equipment in the field of drug analysis, mainly including ICP-MS, LC-HRMS, LC-MS/MS, GC-MS/MS and GC-MS, IC, DSC, IR, UV, High Performance Liquid Chromatography (equipped with UV, DAD, ELSD, CAD and other detectors), GC and so on. The test data collection and processing system has the online audit tracking function, which can provide safe, accurate, reliable and traceable test data and results for drug research and development enterprises.
The center has established joint laboratories or strategic partnerships with internationally renowned instrument companies such as Shimadzu, Agilent, ThermoFisher, AB Sciex and so on to jointly solve all kinds of difficult problems in the process of drug research and development, and realize the strong combination of the core technology of pharmaceutical research and the world's advanced instruments. The research and development of innovative drugs involves a variety of complex processes, and modern instrumental analysis methods play a very critical role in the relevant stages of new drug research and development.
Business Scope
♦Based on advanced testing equipment and perfect quality management system of Leadingpharm, the Analytical Testing Center can help the project team complete the development of complex compound testing methods, compatibility research (packaging materials, drug delivery devices, production components, etc.) and the detection of special impurities (elemental impurities, genotoxic impurities, gold ions, polymers, etc.).
The main business areas of the Center are as follows:
Innovative Topics and Technology Leading
1) Development of a Method for the Detection of Cephalosporin Polymer Impurities by Three-dimensional Chromatography/mass Spectrometry;
2) Establishment of SEC-RPLC-QTOF
Two-dimensional Liquid Phase High Resolution Mass Spectrometry Detection Platform;
3) Development β- Digital Standard Spectrogram Library of Lactam Antibiotics
4) Establishment of Genotoxic Impurity Detection Method Database
5) Mass Spectrometry Study on Characteristics of Drug Packaging Materials and High End Excipients
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