APR 17, 2023 10:00 – 12:00 AM (CET)
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Crystalline purity and crystalline impurities in pharmaceuticals: pushing analytical boundaries using state-of-the-art instrumentation and methods
In the field of pharmaceutical development of New Chemical Entities, the design of the formulation needs to adapt to the physico-chemical properties of the active pharmaceutical ingredients, aiming to ensure appropriate safety, efficacy and performance along preclinical and clinical activities.
The relevance of crystalline forms and crystalline purity against other solid forms, such as polymorphism, pseudo polymorphism, or other salt forms are often critical.
In specific cases, it requires to bridge strong understanding of the solid-state landscape of these active pharmaceutical ingredients with state-of-the-art analytical methodologies. During this discussion, you will be guided through relevant contextual information and expectation of Health Authorities with concrete examples where solid forms were potentially affecting some quality attributes and up to date laboratories approaches were not able to answer all the questions addressed. Accurate answers in a timely manner call for innovative and performant analytical methodologies involving the use of synchrotron radiation as well as methodologies optimized for the analysis of organic pharmaceutical compounds. We will discuss the advantages of high-resolution and high-sensitivity synchrotron X-Ray Powder Diffraction technique allowing us to access unprecedented limit of detections, identification of crystalline impurities and phase purity assessment. The importance of the synergies, understanding of the potential problem statements and adaptation of the data collection set up and post data processing will be highlighted.
Link to the poster of this event.
