Type of Posting: 
Notice of Adoption of Harmonized Standard
Official Date: 
Expert Committee: 

A harmonized standard for Butylparaben has been approved by the Pharmacopeial Discussion Group (PDG) as described in its PDG Sign-Off Cover Page. Having reached Stage 6 of the PDG process, the Butylparaben monograph has been formally approved by the USP Monographs—Excipients Expert Committee in accordance with the Rules and Procedures of the 2010–2015 Council of Experts.

Changes from the existing USP–NF monograph include:

  • Replacing the current TLC method for Related Substances and titration method for Assay with one HPLC method for both tests

Should you have any questions about the Butylparaben monograph, please contact Kevin Moore (301-816-8369 or ktm@usp.org). For any questions about the PDG and its processes, please see the Pharmacopeial Harmonization Web page or contact Mario Sindaco (301-816-8246 or mys@usp.org).

*The PDF that originally posted with this Notice of Adoption contained tags specifying an official publication in Supplement 2 to USP 35–NF 30. The tags have been corrected to Supplement 2 to USP 36–NF 31.

**The PDF that posted with this Notice of Adoption referenced General Chapter <197> in Identification section A. The text has been corrected to refer to the specific preparation method <197M>.