Type of Posting: Revision Bulletin
Posting Date: 22–Mar–2013
Official Date: 01–Apr–2013
Archive Date: 09–Feb–2015
Expert Committee: Monographs—Small Molecules 2
Reason for Revision: Compliance
In accordance with the Rules and Procedures of the 2010–2015 Council of Experts, the Monographs—Small Molecules 2 Expert Committee has revised the Esmolol Hydrochloride monograph. The purpose of this revision is to accommodate the sponsor's FDA-approved impurity specifications listed below:
- Add a process specific impurity, Esmolol Isopropyl amide analog, with an acceptance criteria of NMT 0.25%.
- Widen the acceptance criteria listed in Table 2 under Organic Impurities section as follows:
- Esmolol dimer: from NMT 0.15% to NMT 0.5%
- Esmolol free acid: from NMT 0.3% to NMT 0.4%
- Total impurities: from NMT 0.7% to NMT 1.0%
The purpose of the revision is also to delete the esmolol aminopentanol analog impurity and the corresponding chemical name in the footnotes from Table 2 and revise the relative retention time for N-Ethyl esmolol from 0.88 to 0.84 to be consistent with the sponsor’s FDA approved specifications.
The Esmolol Hydrochloride Revision Bulletin supersedes the currently official monograph. This Revision Bulletin will be incorporated in the USP 37–NF 32.
Should you have any questions, please contact Sujatha Ramakrishna, Ph.D., M.B.A. (301-816-8349 or sxr@usp.org).