Exclusive technical platform
1、Crystal form research :
The platform has crystallizing process development and crystal form characterization devices including X-ray powder diffractions (XRD), thermal gravimetric analyzer (TGA), differential scanning calorimeter (DSC), infrared spectroscopy (HR), hot stage microscope and infrared spectrometer and conducts pharmaceutical research on crystal form screening, drug crystallization control, crystal stability, etc.
2、Reaction thermal risk evaluation
Equipped with Mettler Telodo RC1e TM automatic laboratory reaction calorimeter, differential scanning calorimeter (DSC) and accelerating rate calorimeter (ARC), the platform can carry out full and quantified reaction risk studies and process risk evaluation on drug synthesis processes and provide process design with reliable safety technical data. Meanwhile, it conducts safety risk evaluation on new processes before pilot production and production processes in use to ensure work safety.
3、Research of impurities
With a variety of high-end separators for impurities including DC200 preparative liquid chromatographs, DC600 preparative liquid chromatographs and waters preparative liquid chromatographs, high-end analyzers (such as HPLC-TOF, GC-MS) as well as high-skilled technicians and analysts, the platform can perform preparation of impurities (including synthesis and separation), analysis of impurities (impurities structure identification, and content calibration), as well as the analysis, detection and evaluation of genotoxic impurities.
4、Research of semi-solid preparations
The company boasts of a team of veterans in semi-solid preparations development and devices including imported small emulsification tanks, rheometer and hot stage microscopes, which can facilitate the development of preparations for transdermal and transluminal drug delivery. At the company, the research and development of products including virginal gel preparations and skin external preparations is underway. Meanwhile, the platform has cooperated with overseas top-notch preparation R&D companies to develop strategic varieties and improve its R&D performance.
5、Research of inhalants
The company has established an inhalation technical R&D platform for spray, nebulized drugs and dry powder inhalation. With a wide range of R&D and detecting instruments including high performance liquid chromatographs, high-speed dispersers, laser particle analyzers, cascade impactor (ACI, NGI), spray discharge pattern testing system, automatic particle imaging, chemical component analyzers, etc., the platform is capable of developing inhalations for pulmonary drug delivery. Besides, the platform also works to develop high-end generic drugs and reformed drugs and preparations.
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