USP: Excipient Stimuli published for Comments

Recommendation

28/29 February 2024

Handling of Foreign Particles in APIs and Excipients - Live Online Training
Risk analysis, preventive measures and incident management

In the beginning of September, the stimuli document "Proposed Definitions of Excipient Components- Revisions to 2018 Definitions- PF 49(5)" was published on the USP Pharmacopeial Forum website for comments. Comments on this draft can be submitted until 30 November 2023.

This draft is divided into the following chapters:

• Background 
• Newly Proposed Definitions 
• Appendix
  o Original 2018 Definitions
  o History of Concomitant Component 
• References

Table 1 of the paragraph "Newly Proposed Definitions" shows the new proposals for the excipient components and compares them with the previous definitions of the last valid version from 2018. This is followed by examples for each of the definitions. These include five examples each for main components and minor components as well as seven examples for excipient impurities.

The Stimuli document "Proposed Definitions of Excipient Components- Revisions to 2018 Definitions- PF 49(5)" can be viewed and commented on after a one-time registration on the Pharmacopeial Forum website.