Type of Posting: Notice of Adoption of Harmonized Standard

Posting Date: 30–Nov–2012; updated 11–Jan–2013*; updated 11–Feb–2013** (updated 28–Feb–2017***)

Official Date: 01–Dec–2013

Expert Committee: Monographs—Excipients

***Coordinating Pharmacopeia: EP

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 Dr. Tong (Jenny) Liu (240-221-2072 or jyl@usp.org). For any questions about the PDG and its processes, please see the Pharmacopeial Harmonization Group or contact Richard Lew at (240-221-2060 or rll@usp.org).

***The previous PDG sign-off Cover Pages and Stage 6 postings are included as below:

*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>.