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Loratadine Oral Solution

Type of Posting: Revision Bulletin

Posting Date: 29–Apr–2011

Official Date: 01–May–2011

Expert Committee: Monographs—Small Molecules 4

Reason for Revision: Compliance

In accordance with the Rules and Procedures of the 2010–2015 Council of Experts, the Monographs—Small Molecules 4 Expert Committee has revised the Loratadine Oral Solution monograph. The purpose for the revision is to widen the pH range from "2.5–3.1" to "2.2–3.1", to accommodate the sponsor's FDA-approved acceptance criteria.

The Loratadine Oral Solution Revision Bulletin supersedes the currently official monograph. The Revision Bulletin will be incorporated in USP 35–NF 30.

Should you have any questions, please contact Mary Waddell (301-816-8124 or