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API solid state property testing
Different crystal forms of the same drug have significant differences in stability, manufacturability and bioavailability, which directly affect the efficacy and safety of the drug, therefore, any new drug development requires comprehensive solid-state testing of crystal forms. Accurate and rapid solid-state characterization can not only indicate the direction of drug development, significantly shorten the drug development cycle, reduce the cost and increase the success rate of drug development, but also provide a great help to the subsequent development of the manufacturing process.
Instruments (in part)
HPLC, Waters ACQUITY ARC
High performance liquid chromatography introduces the theory of gas chromatography and is characterized by small and homogeneous resin. It can be used for the qualitative and quantitative analysis of drug molecules. It has the advantages of high column efficiency, high selectivity, high sensitivity, fast analysis speed and good reproducibility.
X-ray diffraction system, RIGAKU SmartLab SE
X-ray diffraction system can record the diffraction line position and intensity with diffraction photon detector and goniometer according to the principle of polycrystalline diffraction to perform crystal diffraction experiment. Its fast detection, high efficiency and accuracy are widely used in various qualitative and quantitative experiments.
Thermal Gravimetric Analyzer, PerkinElmer TGA8000
Thermal gravimetric analyzer is an instrument that detects changes in the temperature-mass relationship of crystals using the thermal gravimetric method. Its important feature is that it is quantitative and can accurately measure the mass change and the rate of change, and is suitable for crystal quality monitoring, such as melting, evaporation, sublimation, thermal stability, thermal decomposition, etc.
NMR Spectrometer, JEOL 400YH
Nuclear magnetic resonance (NMR) is a spectroscopic technique that applies NMR phenomena to determine the structure of molecules, the research has focused on the spectra of two types of nuclei: hydrogen and carbon spectra. The use of NMR spectrometer to study proteins and macromolecules has become an important technical tool in the field of structural biology.
Differential scanning calorimetry is a thermal analysis method that measures the difference in power input to the specimen and the participant as a function of temperature at a programmed controlled temperature. It can determine thermodynamic parameters of drug molecules, such as specific heat capacity, heat of reaction, heat of transition, phase diagram, reaction rate, crystallization rate, crystallinity, sample purity, etc.
Stereo Microscopes, Olympus SZX16
It is a binocular microscope that causes stereoscopic sensation to both eyes by viewing objects from different angles. There is no need to process the observed object, and it provides great help in observing the crystallization condition, crystal morphology and minute manipulation.
Field Emission Scanning Electron Microscope, Hitachi Regulus8100
Field emission scanning electron microscope is a kind of electron microscope. It has ultra-high resolution and can perform secondary electron image and reflection electron image observation and image processing of surface morphology of various solid samples.