Principal scientist United States Pharmacopeia (USP) Rockville, Maryland
USP has been expanding the current compendial monograph standards development process by using iterative approaches to standards development. USP published several stand-alone General Chapters (GC) including < 312>, < 313>, and < 314> to enable stakeholders (industry, regulators, pharmacopeias, etc.) to use advanced analytical methods to enhance characterization and quality of polymeric excipients, prior to the methods being ready to be included in related official monographs. Additionally, USP is developing several new monographs for Lactide (or Lactic acid) and Glycolide (or Glycolic acid) polymers (LG polymers). USP is using a similar approach to support stakeholders’ needs by developing GCs to introduce new methods for LG polymers, including NMR number-average molecular weight determination and GPC molecular weight and polydispersity determination. These methods can also help establish public quality specifications for additional LG polymers that are on the market, but not yet eligible for compendial admission.
Learning Objectives:
Introduce USP’s new stakeholder engagement model.
Elaborate USP’s general chapter iterative approach on modern analytical methods for polymeric excipients.
Discuss USP’s advanced methods for polymeric excipients.