Polymorph Screening Services in Pharmaceutical Compounds
The importance of understanding and controlling the crystalline form produced is important.
Through our polymorph screening services we can perform multiple crystallisation screens to investigate solid-state polymorphism. Using a variety of techniques, we aim to identify and characterize all relevant polymorphic forms as well as any hydrates or solvates of your API.
Polymorph screening in pharmaceutical development
It is a regulatory requirement that the polymorphic landscape of any approved pharmaceutical be well understood and controlled.
It is therefore important that the most stable and optimised form is identified and produced early in Pharmaceutical Development. This reduces the risk that unexpected adverse events, such as batch to batch variability, instability, processing issues and increased hygroscopicity, may occur later.
Drug Development Solutions can perform screens to investigate and understand the solid-state polymorphism associated with your compound. Using a variety of techniques, we aim to identify and characterize all major polymorphic forms as well as any hydrates and the potential for solvation of your API.
Why a polymorph screen may be needed:
- First crystallisation of an otherwise amorphous API
- To identify polymorphs of salts or cocrystals from prior screens
- To generate I.P. with novel advantageous polymorphs
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Polymorph Screening Motivation and Theory
Read more about Polymorph Screening Motivation and Theory in our in-depth article.