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.