Analytical Chemistry

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Service

• Analytical Chemistry Services
  The Medicilon analytical chemistry team is equipped with a variety of advanced analytical instruments and equipment, such as NMR, LCMS, HPLC, SFC, etc., to provide professional analysis and separation and purification services for the drug development process:
  Chiral analysis method development (HPLC+SFC)Chiral separation from milligram to kilogram scale (HPLC+SFC)Prep-HPLC (UV+MS+ELSD trigger)Purification and structure analysis of impuritiesCompound structure confirmation research and reporting: EA, HRMS, NMR, IR, UVDetermination of compound solubility and stabilityRoutine analysis and testing services:   NMR 1D, 2D, etc. (including H-NMR, C-NMR, P-NMR, F-NMR, DEPT, HSQC, HMBC, COZY, NOESY, etc.), QNMRLC-MS analysis (DAD+ELSD detectors)HRMS analysisHPLC analysis (DAD/CAD/ELSD/RID detectors)GC and GCMS analysis (headspace + direct injection)Residual solvent determinationRoutine physical and chemical testing (ROI, ICP-MS, IC, XRD, DVS, IR, UV, MP, optical rotation, KF, titration, heavy metal residue detection, etc.)Thermal Analysis (TGA, DSC)Determination of physicochemical constants: LogP, LogD, pKa determination
• Process Analysis Service
  High-resolution mass spectrometry(QTOF)IPC support for processesCharacterization of reference standardsPre-validation and method transfer of analytical methodsMicroorganisms, endotoxins and bioburden testingReaction Safety EvaluationWater content by KFStability studies according to ICH guidelinesRelease test of raw materials, intermediates and final APIsPhysical and chemical properties testingMethod development and method validaitonMethod development and validation of APIs (according to FDA, EMA, NMPA, and ICH guidelines)Development and validation of residual solvent-related methods (according to NMPA, FDA, EMA , ICH, etc.)
• Drug impurity analysis
  Separating and monitoring impurities in starting materials, intermediates, APIs, and final productsCollection of comprehensive data sets – including 1D/2D NMR, LCMS, EA, HRMS, IR and UV for identifying the structures of separated impuritiesIsolation and identification of API degradation products via forced oxidationUse of QNMR for rapid determination of contents in crude materials, intermediates, APIs and synthetic impuritiesPreparation of IND filingsTo evaluate potential genotoxic impurities (PGI) using QSAR software, to develop, validate and test the PGI in samples

Analytical Technology

• NMRHPLC (DAD/CAD/RID/ELSD)GCGC-MS, GC-MS/MSLC-MS, LC-MS/MSUPLC-MS/MSICP-MSICSFC/UPCCDSC/TGADVSTOCXRPDPSD/PLMPSDPrep-HPLC

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