Solid Form Analysis: In-depth Understanding of API’s Behavior

Solid form analysis plays a vital role in material characterization throughout the whole pharmaceutical development cycle. Setting meaningful and realistic specifications for pharmaceutical product Critical Material Attributes (CMAs) is an important step in ensuring a product meets its target performance profile.

Within this, the polymorphism and crystallinity of the Active Pharmaceutical Ingredients (APIs) present in the product formulations are crucial. The presence of an undesired polymorph could lead to a reduction in therapeutic benefit, due to changes in API solubility, and may even cause an adverse effect to the patient.

Structural analysis becomes even more important when an amorphous form of the API is selected to improve solubility, as unexpected crystallization of an insoluble form can be fatal. X-ray Powder Diffraction (XRPD), being one of the solid form analysis methods, is a comprehensive technique that provides a deep understanding of the API’s structure, its stability and behavior in a drug product.

Présentateur

  • Dr. Natalia Dadivanyan - Field Application Scientist X-ray Products, Application & Business Development Pharma & Food Sector, Malvern Panalytical
  • Mike Auerbach - (Moderator) Editor-in-Chief, American Pharmaceutical Review

Questions les plus fréquentes

In this webinar you’ll learn:

  • How to evaluate stability of a formulation early in the drug product development process
  • What impact can distribution of components within pharmaceutical solid dosage forms make on the product quality
  • How to evaluate amorphous content and structure of amorphous ingredients in drug products


Who should attend:

  • Anyone who is developing pharmaceutical formulations
  • Anyone involved in stability studies
  • Researchers engaged in chemical development or support of scale up activities
  • Anyone engaged in producing or setting specifications for pharmaceutical raw materials or intermediate