Type of Posting: Revision Bulletin
Posting Date: 30–Sept–2010
Official Date: 01–Oct–2010
Expert Committee: Monographs—Small Molecules 1
In accordance with the Rules and Procedures of the 2010–2015 Council of Experts, the Monographs—Small Molecules 1 (SM1) Expert Committee has revised the Oseltamivir Phosphate Capsules monograph. The purpose of the revision is to accommodate the sponsor's FDA-approved specifications for the following:
- Under Dissolution, revise the tolerances from NLT 80% (Q) at 20 min to NLT 75% (Q) at 20 min
- Under Organic Impurities,
1. Widen the limit of Impurity A from NMT 1.0% to NMT 2.0%
2. Widen the limit of Impurity C from NMT 0.2% to NMT 0.5%
3. Widen the limit of Total impurities from NMT 1.5% to NMT 3.0%
The Oseltamivir Phosphate Capsules Revision Bulletin supersedes the currently official monograph and will be incorporated in the First Supplement to USP 34–NF 29.
Should you have any questions, please contact Leonel Santos (301-816-8168 or lxs@usp.org) or Margareth Marques (301-816-8106 or mrm@usp.org).