Method Development — API 

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Method Development — API 

The Challenge

Develop Analytical Methods to Support Pre-Clinical and Future GMP Production, Release and Stability Testing

The Barriers

  • No previous analytical data
  • Challenging analytical chemistry
  • Sponsor had no prior chemical knowledge on the compound or synthesis
  • Tight timelines

Analytical Services

  • Develop analytical methods to assess SM, IM and API purity
  • Develop analytical methods to identify and separate impurities
  • Use MS techniques to understand impurity formation and control in API and starting materials (SMs)

Analytical Results

  • Developed methods suitable and phase-appropriate for future GMP use
  • Separated impurities and developed background to set GMP phase-appropriate specifications for SMs, IMs and API
  • Analytical methods worked so well the client used them to analyze pre-clinical samples to get PK / distribution data, previously thought unattainable 

Due to the similarity in API and impurities, separation and retention was a challenge.

* Screening involved pH, mobile phases, columns, gradients, column temperature

The Outcome

  • Developed methods suitable for future GMP support
  • Delivered on time
  • Client awarded Avista 2 additional challenging analytical projects

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