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 Dehydrated 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 Dehydrated 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 Standard solution B, changed “10 µg/L” to “10 µL/L” for Acetaldehyde.
- For consistency purpose, changed the Split ratio in Chromatographic system to “20:1” from “1:20”.
- 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 to the footnote.
- Ultraviolet Absorption:
- Changed the analytical wavelength from “200–400 nm” to “235–340m” to be consistent with the Alcohol monograph.
In addition, the monograph has been edited to be consistent with the current USP style guide.
The Dehydrated 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 Dehydrated Alcohol monograph, please contact Kevin Moore (301-816-8369 or firstname.lastname@example.org). For any questions about the PDG and its processes, please see the Pharmacopeial Harmonization Web page or contact Emily Meyer (301-230-7438 or email@example.com).
- Download the Dehydrated Alcohol monograph*
- Download the Dehydrated Alcohol PDG sign-off cover sheets:
*A minor correction was made to the revision tagging in the monograph. The content of the monograph has not been altered.