Type of Posting: Revision Bulletin
Posting Date: 30–May–2014; updated 27–Jun–2014*
Targeted Official Date: 01–Jun–2014
Expert Committee: Monograph—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 Methylphenidate Hydrochloride Extended-Release Tablets monograph. The purpose for the revision is to add a dissolution Test 3 and Test 4 to reflect products approved by the FDA.
The liquid chromatographic procedure in Dissolution Test 3 is based on analyses performed with Luna C18(2)-HST brand of L1 column manufactured by Phenomenex. The typical retention time for methylphenidate is about 1.8 min.
Dissolution Test 4 is based on analyses performed with ACE C18 brand of L1 column manufactured by Advanced Column Technologies. The typical retention time for methylphenidate is about 4.5 min. In addition, Table 6 listing all the degradation products has been revised to delete the chemical name of USP Methylphenidate Related Compound A RS from the footnote, because it is already in the USP Reference Standards section of the monograph.
This Methylphenidate Hydrochloride Extended-Release Tablets Revision Bulletin supersedes the currently official monograph. The Revision Bulletin will be incorporated into USP 38–NF 33.
Should you have any questions, please contact Ravi Ravichandran, Ph.D. (301-816-8330, rr@usp.org).
*There was an error in the Revision Bulletin for Methylphenidate Hydrochloride Extended-Release Tablets that was posted on May 30, 2014. In Dissolution Test 3, the HPLC procedure uses a flow gradient (table 3). The unit of measure was incorrectly indicated on this table as hours, instead of minutes. The Revision Bulletin has been corrected to indicate minutes as the unit of measure for Dissolution Test 3, Table 3.