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) and excipients present within a product formulation are crucial. 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. Polymorph selection, and conformation of polymorphic stability over time, is therefore vital. This 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.
In this second webinar in the series, we will discuss how XRPD method development and verification can be achieved in line with quality assessment requirements. We will consider how the use of different sample preparation techniques and instrument geometries can impact the outcome of an XRPD experiment. We will then look at the regulatory guidance relating to the assessment of the precision, robustness and ruggedness of the method.
Our goal will be to provide a process for defining an appropriate method that is able to rigorously support product quality control assessments while being flexible enough to be realistically applied throughout the lifetime of a pharmaceutical product.