USP: Updated Excipient List published for Comment

Recommendation
30 June - 2 July 2025
Copenhagen, Denmark
Part of the ICH Q7 Training Courses 2025
At the beginning of July 2024, the document 'Excipients, USP and NF Excipients, Listed by Functional Category' was published for comment on the USP Pharmacopeial Forum website. Comments and observations on this draft can be submitted until 30 September 2024.
This draft groups the excipients into categories to show their use in certain dosage forms of finished medicinal products. It is explicitly pointed out that the use of these excipients is not limited to the listed functions in certain pharmaceutical forms. The revised draft is divided into the following points:
- Biodegradable Polymer
- Coating Agent
- Diluent
- Emollient
- Emulsifying Agent
- Film-Forming Agent
- Lubricant
- Polymeric Membrane
- Polymers for Ophthalmic Use
- Release-Modifying Agent
- Solubilizing Agent
- Solvent
- Wet Binder
You can view and comment on this draft 'Excipients, USP and NF Excipients, Listed by Functional Category' after a one-time registration on the website of the Pharmacopeial Forum.
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