Analytical Chemistry

Our discovery analytical and purification teams provide high quality analytical and separation services to both internal and external clients. Our experts in this field have built a solid reputation as demonstrated by a high rate of repeat business.

Impurity Analysis

  • Isolation of impurities of regulatory starting materials, intermediates, APIs and drug products using various techniques including preparative HPLC and SFC
  • Structure elucidation of isolated impurities by acquisition and interpretation of comprehensive 1D/2D NMR and LCMS data
  • Isolation and structure elucidation of forced oxidation degradants of APIs
  • Fast purity determination of raw materials, intermediates, APIs and synthetic impurities by quantitative NMR (QNMR)
  • Professional document preparation for filings

High-throughput Physicochemical Property Determination

  • Thermodynamic and kinetic solubility by LC-CLND method
  • Log P/Log D determination utilizing shake-flask
  • pKa determination by potential metric titration method

Method Development and Verification Methodology

  • Method validation of API ( in accordance with the ICH requirements or other client specifications)
  • Residual solvent method validation (in accordance with the ICH requirements)

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