USP Excipients update – February 2024 

USP Novel excipient information hub  

In a recent USP survey, 77% of respondents stated their concerns and challenges in advancing drug formulation using novel excipients. USP created a novel excipient information hub in response to this survey, where you can tell USP your challenges with novel excipients. Your input will help USP prioritise focus areas and explore new platforms (e.g., technical guides, application notes, exchange community, etc.) to engage with you. Visit the Novel Excipients information hub.

Latest Excipient Reference Standards 

The latest USP Excipient Reference Standards (RS) are available at the USP Store

New Pharmacopeial Forum postings 

A list of proposed Excipient monographs and general chapters, along with their date of publication is included in the Pharmacopeial Forum. Stakeholders have 90 days from the date of publication to submit comments. Comments are still open on the December 2023 proposed Excipient monographs and general chapters. Please submit any comments directly to USP here.

December 2023 – PF 50(2) 

  • Crospovidone4 
  • Diethylene glycol monoethyl ether4 
  • Hydroxypropyl betadex2 
  • Maltitol4 
  • Maltitol solution4 
  • Maltose4 
  • Noncrystallizing sorbitol solution4 
  • Sodium oleate1 
  • Sorbitan monooleate2 
  • Sorbitan monostearate2 
  • Sorbitan sesquioleate2 
  • Sorbitol4 
  • Sorbitol solution4 
  • Sorbitol sorbitan solution4 
  • Stearyl alcohol4 

Key: 1 = New; 2 = Modernization; 3 = Harmonization; 4 = Revision; 5 = Major Revision; 6 = Omission 

Official monographs and General Chapters 

Below is a list of recent excipient monographs and general chapters along with the dates on which they became official. See the USP-NF Publication/Official schedulehere

USP–NF 2024, Issue 1 

  • <1059> Excipient Performance4 
  • Aspartame acesulfame6 
  • Boric acid2 
  • Carrageenan2 
  • Cocoyl caprylocaprate1 
  • Ethyl butyrate1 
  • Formic acid1 

USP–NF 2024, Issue 2 

  • <312> Molecular Weight Determination for Alginates1 
  • Carbomer 13426 
  • Carbomer 9346 
  • Carbomer 934P6 
  • Carbomer 9406 
  • Carbomer 9416 
  • Dextrose4 Liquid glucose2 

Key: 1 = New; 2 = Modernization; 3 = Harmonization; 4 = Revision; 5 = Major Revision; 6 = Omission 

Excipients spotlight -Emollients 

Because excipients that are emollients are in the final drug product, the quality of such excipients is critical. USP documentary and Reference Standards can help ensure the quality of the emollients in the drug formulation. 

The following general chapter may be useful in ensuring consistency in selected emollient functions: <401> Fats and Fixed Oils

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