Type of Posting: Notice of Adoption of Harmonized Standard
Posting Date: 21–Nov–2014 (updated 27–Feb–2017*)
Targeted Official Date: 01–Dec–2015
Expert Committee: Monographs—Excipients
*Coordinating Pharmacopoeia: European 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 Dr. Tong (Jenny) Liu (240-221-2072 or email@example.com). For any questions about the PDG and its processes, please see the Pharmacopeial Harmonization Group or contact Richard Lew at (240-221-2060 or firstname.lastname@example.org).
- Download the Alcohol monograph –Stage 6
- Download the Alcohol PDG sign-off documents:
- *Previous Stage 6 web posting (22–Nov–2013; Official Date 01–Dec–2014)
- Previous Stage 6 web posting (posted 27–Sep–2013; updated 08–Oct–2013; Official Date 01–Aug–2014)
- Previous Stage 6 posting in PF 30(5), 2004
- Previous Stage 6 posting in PF 30(2), 2004
- Previous Stage 6 posting in PF 29(5), 2003