Analysis Center
2014-07-21 23:10:48 Author:admin
     
    Analytical center consists of two functional groups: Quality Inspection and Quality Control. Quality Inspection is responsible for generating analytical data of new drugs for CRCD. Its major role is to evaluate physicochemical properties of substances as well as test and monitor compound purity for the synthesis center and API scale-up center. It is also responsible for structure confirmations for API, positive control drugs, and metabolites and impurities of reference substance. Quality Control is responsible for generating analytical data of new drugs for IND. The main role of QC is to follow Chinese/international guidelines and study the quality of API and drug products, including appearance, identification, and impurity concentration. Another role of QC is to provide the stability test for API and new drug product so as to determine their  proper packaging, storage conditions and expiration date.
    Analytical Center is equipped with advanced instruments including NMR, LC-MS, high pressure preparative chromatography, HPLC, GC, FT-IR, laser particle size analyzer, XRD, TGA, DSC. The full set of equipment provides a comprehensive analysis platform for new drug development.


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