Fate and Purge

Drug substances produced by chemical syntheses contain impurities (organic, inorganic, elemental, or residual solvents) which must be controlled in order to ensure the desired product quality. The various Regulatory Authorities require that impurities above a certain threshold be identified and tracked, and that all mutagenic and genotoxic impurities be reported at any level. Critical Quality Attributes (CQA) of the drug substance and all isolated intermediates need to be identified, justified, and included in the specifications. Generation and depletion of impurities which are formed during chemical syntheses or due to limited stability of intermediates should be investigated in a “fate and purge” study.

Services include:

  • Identify and Justify Critical Quality Attributes
  • Implement Control Strategy
  • Fate & Purge Studies
  • Determination of Carryover
  • Technical Assessments and Consultation
  • Method Development & Validation
  • Luminata™ Software for Tracking, Mapping Impurities and Reporting

Characterization Techniques:

  • UPLC/MS
  • LC/MS/MS
  • HRMS
  • Modeling software (SpartanPro)
  • FTIR
  • ICP-MS
  • NMR
    • 400 MHz and 600 MHz with cryogenic probe
    • 1H, 13C
    • 2D NMR Techniques:
      • COSY, HMBC, HSQC, DEPT 135
    • Other nuclei available at a local partner

Services include:

  • Identify and Justify Critical Quality Attributes
  • Implement Control Strategy
  • Fate & Purge Studies
  • Determination of Carryover
  • Technical Assessments and Consultation
  • Method Development & Validation
  • Luminata™ Software for Tracking, Mapping Impurities and Reporting

Characterization Techniques:

  • UPLC/MS
  • LC/MS/MS
  • HRMS
  • Modeling software (SpartanPro)
  • FTIR
  • ICP-MS
  • NMR
    • 400 MHz and 600 MHz with cryogenic probe
    • 1H, 13C
    • 2D NMR Techniques:
      • COSY, HMBC, HSQC, DEPT 135
    • Other nuclei available at a local partner

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