Alcohol

Type of Posting: Notice of Adoption of Harmonized Standard

Posting Date: 21–Nov–2014

Targeted Official Date: 01–Dec–2015

Expert Committee: Monographs—Excipients

Coordinating Pharmacopoeia: Japanese Pharmacopoeia

The correction to harmonized standard for Alcohol has been approved by the Pharmacopeial Discussion Group (PDG) as described in its PDG Stage 6 Rev. 2 Corr. 2 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:

  • Ultraviolet Absorption
    • Corrected the Acceptance Criteria to “Curve: The spectrum shows a steadily descending curve with no observable peaks or shoulders.” from “Curve: The spectrum shows a steadily rising curve with…”
  • Organic Impurities
    • Minor editorial changes according to USP Style guide by adding “μL/L” after the definition of concentrations of CA, CD and CM.

The Alcohol monograph will be incorporated into and become official with the Second Supplement to USP 38–NF 33.

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).