Excipients play a critical role in assuring the performance and quality of a pharmaceutical product. As such, appropriate control of the critical properties of excipients is necessary. USP and NF monographs provide methods and specifications for many of the key physical, chemical, biological, or microbiological properties important in assuring excipient quality. But monographs do not necessarily provide methods or specifications for every property necessary. The purpose of USP General Information Chapter is to explain how excipients may be used in formulations and how they relate to compendial specifications, performance-related properties (PRPs), critical material attributes (CMAs), and quality by design (QbD) principles that aid in their selection and control. Some discussion of approaches that can be used to determine what properties should be considered as critical are included to demonstrate how Chapter may be used to facilitate the process of determining and testing for properties that may be critical to product quality and performance.
Become familiar with USP Informational General Chapter <1059> Excipient Performance and revisions.
Enhance understanding of the critical role of excipients in dosage form performance.
Understand how <1059> can assist in identifying and quantifying excipient critical material attributes of excipients.
Relate <1059> to Quality by Design principles (QbD).