Test Article Management and Analysis Center
The Test Article Management and Analysis Center provides test article analysis services for chemical drugs, traditional Chinese medicine, and biological products. A comprehensive management system for test samples has been established, with independent test sample management and preparation laboratories, and a dedicated darkroom (yellow light illumination) for the preparation of dark drugs. The laboratory is equipped with drying cabinets, refrigerated refrigerators, low-temperature refrigerators, liquid nitrogen tanks, clean workstations, etc., which can meet the requirements for the preservation and preparation of chemical drugs, traditional Chinese medicine, and biological products. Research scope: 1 Analysis of test samples for chemical drugs, traditional Chinese medicine, and biological products: development, transfer, optimization, and validation of methods such as high-performance liquid chromatography (HPLC) and liquid chromatography-mass spectrometry (LC-MS/MS); Homogeneity, stability, and concentration or content determination of the test sample after preparation. 2. Analysis of test samples for cell drugs: Cell viability and cell suspension concentration of stem cell products were measured using a cell counter combined with an inverted optical microscope (cell counting plate) and trypan blue staining method. 3. Test article analysis of special preparations: gel preparations shall be extracted with appropriate solvent and determined by HPLC or LC-MS/MS for content, homogeneity and stability; Inhalation of the preparation, selection of appropriate good solvents for scientific collection of the analyte (aerosol collected using filter paper adsorption method), combined with HPLC or LC-MS/MS method for content, uniformity, and stability determination.