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Impurity Isolation and Identification

Impurity Isolation and Structure Elucidation

Isolation and identification of impurity/degradant of APIs and DPs to support process optimization and regulatory filing.  

Impurity Isolation

  • Isolation of impurities in starting materials, intermediates, APIs and drug products using efficient separation techniques including preparative HPLC and SFC
  • Isolation of the degradation products of APIs from forced degradation studies
 

Impurity Structure Elucidation

  • Structure elucidation of isolated impurities by acquisition and interpretation of comprehensive 1D/2D NMR, MS and IR data
  • Fast purity determination of raw materials, intermediates, APIs and synthetic impurities by quantitative NMR (QNMR)
  • Impurity identification and analysis based on customers’ needs
  • Professional document preparations for filings.
 

General Service Workflow

   

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