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The company is equipped with independent facilities, equipment and advanced analytical instruments, such as HPLC, GC, HPLC-MS, GC-MS, GC-HS, DSC, ICP, IR, KF, etc., which can meet the requirements of various chemical raw materials and intermediates. Test items, such as related substances, content, solvent residues, heavy metals and genetic impurities. Analytical method development, quality index establishment and analytical method validation.
The company has set up a professional analysis team, strictly implements cGMP management in accordance with the quality management requirements of ICH, and has passed the inspections of FDA, PMDA and CFDA and other drug regulatory authorities for more than ten years.