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Crystal form screening & Developability Assessment+ 查看更多
1. Crystal form screening
2. Characterization and preparation
• Powder X Ray Diffraction (PXRD)
• Thermal Gravimetric Analyzer (TGA)
• Differential Scanning Calorimetry (DSC)
DSC is a thermal analysis method that measures the power difference between the input to the specimen and the reference material as a function of temperature at a specific program-controlled temperature. With a wide temperature range (-175-725°C), high resolution and low specimen usage, this technique is widely used for the analysis of organic compounds, pharmaceuticals etc. It can quickly and accurately measure a wide range of thermodynamic and kinetic parameters such as reaction rate, crystallization rate, crystallinity, sample purity etc.
• Gas Chromatography (GC)
GC is a chromatographic method using gas as the mobile phase, which can be further divided into gas-liquid chromatography and gas-solid chromatography according to the different stationary phases. Gas chromatography has the advantages of high separation efficiency, low sample usage, high detection sensitivity and a wide range of applications. Depending on the type of resins used, gas chromatography can perform qualitative and quantitative analysis of drugs, determination of impurities, residual solvents, monitoring of drug intermediates, etc.
3. Crystal form evaluation
After preparing different crystal forms of the same drug molecule and obtaining their respective characterization information through a variety of techniques, the crystallization phase of the drug will be evaluated. Our team of expert researchers will evaluate each crystal form for its physical and chemical properties, physicochemical stability, process exploitability, interconversion, powder properties, solubility, crystal habit, etc. to ensure the selection of a crystal form with good safety, stability, exploitability and drug efficacy.
Subject:Generic drug crystal form screen
Background:Structure of the API is sugar ring (hydrogen bonded), it is difficult to crystallize, and the original crystal form is a solvate.
Difficulty:None of the conventional crystal form screening methods can obtain an amorphous form (mostly declared as amorphous in China).
Breakthrough: API was frozen with solvent to obtain multiple pipeline solvates, which in turn were desolvated to obtain crystal-free forms. By comparing the physicochemical properties of each crystal form such as melting point, crystallinity and moisture attraction, the crystal form E was finally determined as the declared crystal form.