Benzyl Alcohol

Type of Posting: Notice of Adoption of Harmonized Standard

Posting Date: 19-Nov-2021

Official Date: 01-Dec-2022

Expert Committee: Simple Excipients

Coordinating Pharmacopeia: European Pharmacopeia

A revision to the 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 4 of the PDG process, the Benzyl Alcohol monograph has been formally approved by the USP Simple Excipients Expert Committee in accordance with the Rules and Procedures of the 2020–2025 Council of Experts.

Changes from the existing USP–NF monograph include:

  • Identification test A.
    • Removed the diamond symbols (⧫⧫) from this test because PDG included this new identification test in the PDG global text as a harmonized attribute.
  • Assay
    • Replaced “ethanol (96%)” with “Alcohol” and included a link to the Alcohol -reagent.
    • Deleted “boiling” because there is no need to have a “boiling” water bath when the solution is refluxing.
    • Specified that “Titrant” is “1 N sodium hydroxide VS”.
    • Replaced “1 N sodium hydroxide VS” with “Titrant” in Analysis and Calculation.
    • Added “N” which is the actual normality of Titrant (mEq/mL) in the calculation formula as a USP local requirement. The equation in the PDG global text assumes that sodium Hydroxide solution concentration is exactly 1 N (i.e. mEq/mL). However, USP needs to include the precise normality of sodium hydroxide solution in the calculation based on the standardization of the titrant.

      European Pharmacopeia (EP) and Japanese Pharmacopeia (JP) will perform according to their rules of calculation in EP’s general chapter (4.2.2) and JP’s general chapter <9.21>, respectively.

      Therefore, a sentence is included on the sign-off cover sheet:

      “Each pharmacopeia will consider actual titrant concentration in equations according to their local rules of calculation for titration.”
  • Organic Impurities
    • Replaced “relative retention time” with “retention time” in four places. No impact on the content.
  • Acidity
    • Replaced “ethanol (96%)” with “Alcohol” and included a link to the Alcohol - reagent.
    • Specified the significant figures of maximum volume of titrant which is “NMT 1.0 mL…”
  • Additionally, minor editorial changes have been made to update the monograph to current USP style.

The Benzyl Alcohol monograph will be incorporated into and become official with the USP-NF 2022 Issue 3 (December 1, 2022).
Should you have any questions about the Benzyl Alcohol 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: