Type of Posting: Notice of Adoption of Harmonized Standard
Posting Date: 23–Nov–2011 (updated 27–Feb–2017*)
Official Date: 01–Dec–2012
Expert Committee: Monographs—Excipients
*Coordinating Pharmacopeia: EP
A harmonized standard for Benzyl Alcohol 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 Benzyl Alcohol 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:
- For Assay procedure, change text from "boil under a reflux condenser on a water bath for 30 min," to "heat under a reflux condenser on a boiling water bath."
- Added requirement to use dried pyridine to prevent excess water from converting acetic anhydride to acetic acid.
The Benzyl Alcohol monograph will be incorporated into and become official with the Second Supplement to USP 35–NF 30.
*Should you have any questions about the Benzyl Alcohol monograph, please contact Dr. Tong (Jenny) Liu (240-221-2072 or firstname.lastname@example.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 email@example.com).
*The previous PDG sign-off Cover Pages and Stage 6 postings are included as below:
- Download the Benzyl Alcohol monograph
- Download the Benzyl Alcohol PDG Sign-Off Cover Pages:
- Previous Stage 6 posting in PF 35 (3), 2009
- Previous Stage 6 posting in PF 30 (2), 2004
- Previous Stage 6 posting in PF 28 (3), 2002