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Products & Services / NCE Development and API

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NCE Development and API

  • Analytical Method Development
    • Potency
    • Impurities – forced degradation studies for identification and LCMS/MS as a tool for identification and purification
    • Residual solvents
    • Physical and chemical tests
    • Cleaning assessment
    • Chiral purity
    • Particle size
    • Identification tests (FTIR, NMR, LCMS)
    • Counter-ion
    • X-ray powder diffraction
    • Metals
  • Validation of Analytical procedures
    • Assay of actives
    • Related substances or impurities
    • Cleaning validation
    • Chiral purity/enatiomeric excess
    • Residual solvents by HS-GC
    • Non-specific assay methods (UV & potentiometer)
    • Impurities at trace levels (LC-MS/MS and GCMS)
    • Particle size
    • Estimation of residual metals
    • Microbiology