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Analytical Chemistry

Analytical Chemistry

Medicilon's analytical chemistry, purification and separation team is able to offer high-quality services. We are well-regarded by our clients for our deep experience and problem-solving skills.
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  • 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)Milligram-level to kilogram-level chiral separation (HPLC+SFC)Prep-HPLC (UV+MS+ELSD trigger)Purification and structure analysis of impurityCompound structure confirmation research and report: EA, HRMS, NMR, IR, UVCompound Solubility and Stability DeterminationRoutine 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)Physicochemical constant determination: LogP, LogD, PKa determination
  • Process Analysis Service
    High-resolution mass spectrometry(QTOF)IPC support for processesReference standard characterizationAnalytical method pre-validation and method transferMicroorganisms, endotoxins and bioburdenReaction Safety EvaluationWater content by KFStability study: perform stability study per ICH guidelinesRelease test of raw materials, intermediates and final APIPhysical and chemcial propertiesMethod development and method validaitonMethod development and validation of API (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 productsCollecting complete data sets – including 1D/2D NMR, LCMS, EA, HRMS, IR and UV – to identify the structure of the separated impuritiesIsolating 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 IND filingTo evaluate potential genotoxic impurities (PGI)with 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
Relevant laboratories
  • GC-MS
  • Agilent 1260 LCMS ELSD
  • Agilent 1260_HPLC
  • Gilson-prep-HPLC
  • LCMS-2020
  • Thermo-CAD Ultimate 3000 UHPLC
  • Waters 2767 QDA prep HPLC-ELSD
  • Waters 2767-QDA prep HPLC
  • Waters UPLC
  • Waters-UPLC-QDA
  • LC-20AD-HPLC-ELSD
  • NMR Bruker 400
  • HPLC
  • ICP-MS
  • NMR
  • HPLC
  • SFC
  • TGA
  • Heaven's Room
  • prep-HPLC
  • polarimeter
  • Uhplc
  • Overnight synthesis laboratory
  • Overnight synthesis laboratory
  • Overnight synthesis laboratory
  • High activity laboratory
Relevant articles