Analytical Chemistry

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Chemical analysis services

• Drug impurity analysis
  Separating and monitoring impurities in starting materials, intermediates, APIs, and final products HPLCcomplete data – including 1D/2D NMR, LCMS, EA, HRMS, IR and UV – to identify the structure of the separated impurities CollectingIsolating and identifying the structures of API degradation products by forced oxidation Employment of QNMR to quickly determine the contents of crude materials, intermediates, API and synthetic impuritiesPreparation of professional filing materials
• Method development and methodology verification
  Method development and verification of API (according to  NMPA, FDA, EMA and ICH guidelines, as well as requests of clients)Development and verification of residual solvent-related methods (according to NMPA, FDA, EMA , ICH, etc.)
• General services
  NMR 1D, 2D, etc. (including H-NMR, C-NMR, P-NMR, F-NMR, HSQC, HMBC, COSY and NOESY)LC-MS analysis HPLC analysis (including ELSD detection)Chiral purity testPreparation and separation in Pre-HPLCRoutine physical and chemical tests (ROI, LOD, Cl^-, SO₄^2-, mp, HM, optical rotation, moisture determination, heavy metal residues, etc.)

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