• What is crystallization and why is it essential in API manufacturing
  • Saturated, Supersaturated, and Unsaturated solutions and the solubility curve
  • Nucleation, seeding and crystal growth
  • Solubility limit, metastable zone, and super saturation.
  • Crystal size distribution and polymorphism
  • Antisolvent and reactive crystallization
  • Continuous and batch crystallization
  • A video from a manufacturer of glass line crystallizers, explaining its various parts.
  • Design and safety considerations

Applications of Crystallization in API Manufacturing

Crystallization is a purification technique involving solid formation. This modules covers crystallization in detail, and solution crystallization in particular. It also looks at factors affecting solution crystallization like concentration and temperature.

What's inside

  • What is crystallization and why is it essential in API manufacturing
  • Saturated, Supersaturated, and Unsaturated solutions and the solubility curve
  • Nucleation, seeding and crystal growth
  • Solubility limit, metastable zone, and super saturation.
  • Crystal size distribution and polymorphism
  • Antisolvent and reactive crystallization
  • Continuous and batch crystallization
  • A video from a manufacturer of glass line crystallizers, explaining its various parts.
  • Design and safety considerations

Additional information

Who is it for

This module is relevant to all employees in Engineering, Quality Control, Quality Assurance, and Production of API manufacturing

Why it matters.

Crystallization plays an important role in intermediate separation/purification and final manufacturing of API. Strict control of physical properties and chemical purity of the API is critical because it has an impact on the quality and efficacy of the final pharmaceutical product. Regulatory agencies are increasingly focusing on gaps in the crystallization properties and their consistency in API manufacturing