In accordance with the Rules and Procedures of the 2010-2015 Council of Experts, the Monographs—Small Molecules 2 Expert Committee has revised the Meloxicam monograph. The purpose for the revision is to eliminate the use of USP Meloxicam Related Compound D RS under the test for Organic Impurities, Procedure 2. Recent evaluation of the current lot of USP Meloxicam Related Compound D RS by USP scientific staff has determined that it is not suitable for its compendial usage as described in USP 34–NF29.
The Organic Impurities Procedure 2 is revised as follows:
- System suitability stock solution and System suitability solution are deleted from the monograph, and the resolution requirement between meloxicam related compound D and meloxicam under System Suitability is deleted.
- Meloxicam related compound D is no longer listed in Table 4 as a specified impurity eluting at the relative retention time of 2.4. An impurity eluting at this relative retention time is now controlled as an individual unknown impurity. The limit of this impurity remains unchanged at NMT 0.1%.
The Meloxicam Revision Bulletin supersedes the currently official monograph and will be incorporated in the Second Supplement to USP 35–NF 30.
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