X-Ray Powder Diffraction (XRPD) is ideal for the characterization of (bio)pharmaceuticals, supporting the Quality-by-Design (QbD) approach and the requirements of the new Food & Drugs Administration (FDA) guidance on process validation.
Pharmaceutical drug substances can exist in different crystalline forms (polymorphs), solvates/hydrated forms (pseudo-polymorphs) and amorphous forms, as a result of the manufacturing and storage conditions. These different forms can have a profound effect on the quality or performance (e.g. solubility, bioavailability, efficacy, safety) of the drug product [26-28]. For example, therapeutic failure has been attributed to uncontrolled hydrate formation in tablets during storage .
For this reason, it is now a regulatory requirement to conduct a detailed analysis of the polymorphism of the drug substance and drug product during technical development, including screening, characterization, property determination and setting of acceptance criteria for the different forms (see for instance the ICH Q6A guideline).
"The Gold Standard Technique"
To meet these requirements, XRPD, and even more so SR-XRPD, stands out as the gold standard technique [3,4]. It has thus become a key tool to support research, development, manufacturing and life-cycle management activities for (bio)pharmaceuticals.
Typical applications include
"Not only for pharmaceuticals"
SR-XRPD is a powerful technique in several other areas where the properties and performance of products are dependent on their crystalline structure and relative distribution of their polymorphic forms, such as: