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Small Molecules - API Development & Manufacturing >> Solid State Research and Development >> Crystallization Process Development and Optimization

Crystallization Process Development and Optimization

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Taking a quality by design approach, we offer knowledge-based crystallization process development to achieve robust and scalable crystallizations that yield reproducible high quality solid. A thorough understanding of the solid form accompanied with solubility data is the base of our crystallization process development. Utilizing state-of-the-art instrumentation, we collect all of the crucial solubility data (e.g. solubility and cloud curves, metastable zone width,...) and monitor crystallization process in real time (e.g. FBRM) as well as offline (e.g. PXRD, PSD,…). A fast and efficient knowledge transfer between our solid state and process development scientists assures a polished crystallization process that is focused on the following aspects:

  • Solid form control
  • Chemical purity and residual solvents
  • Particle size distribution control
  • Efficiency and yield

 

Related instruments: Crystal16™, Unchained Labs Junior™, EasyMax™, ParticleTrack G400™, D8 Discover™, D2 Phaser™, Mastersizer 3000™

 

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