Alcohol

Type of Posting: Notice of Adoption of Harmonized Standard

Posting Date: 27–Sep–2013; updated 08–Oct–2013*

Official Date: 01–Aug–2014

Expert Committee: Monographs—Excipients

A revision to the harmonized standard for Alcohol has been approved by the Pharmacopeial Discussion Group (PDG) as described in its PDG sign-off cover sheet. Having reached Stage 6 of the PDG process, the 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:

  • Test for Organic Impurities:
    • For calculation of the limit for Acetaldehyde and Acetal, added a conversion factor in the formula in order to convert the amount of acetal into acetaldehyde equivalents.
    • Included additional clarification on the disregard limit of 9 µL/L in the footnote

In addition, the monograph has been edited to be consistent with the current USP style guide.

The Alcohol monograph will be incorporated into and become official with the First Supplement to USP 37–NF 32.

Should you have any questions about the Alcohol 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 website or contact Emily Meyer (301-230-7438 or eam@usp.org).

*A minor correction was made to the revision tagging in the monograph. The content of the monograph has not been altered.