Type of Posting: Revision Bulletin: POSTPONEMENT
Posting Date: 01–Aug–2007
Revised Date: 13–Feb–2009
Official Date: 01–Aug–2007
Expert Committee: Monograph Development—Pulmonary and Steroids
Transferred to Accelerated Revision History section: 01–Jun–2009
In accordance with the Rules and Procedures of the 2005–2010 Council of Experts, USP is postponing a portion of the Chromatographic purity test and the entire Dissolution test in the Norgestimate and Ethinyl Estradiol Tablets monograph. In the test for Chromatographic purity, the control of the norgestrel acetate impurity from Norgestimate is not adequate due to a co-eluting peak. This revision postpones control of the norgestrel acetate impurity in the Chromatographic purity test. USP will publish a further revision to this test to control the norgestrel acetate impurity upon receipt and review of appropriate supporting data.
In addition, the Dissolution test is postponed in its entirety due to recent information that indicates the tolerances may not be appropriate for all approved products on the market. USP also will publish a revised Dissolution test for this monograph in a future Pharmacopeial Forum as an In-Process Revision.
The Norgestimate and Ethinyl Estradiol Tablets Monograph supersedes the monograph in USP 32–NF 27 until it is printed in the USP 32–NF 27 Second Supplement, which will be released June 1, 2009.
Should you have any questions related to the Chromatographic purity test, please contact Mary Waddell (301-816-8124 or msw@usp.org). Questions related to the Dissolution test should be directed to Margareth Marques, Ph.D. (301-816-8106 or mrm@usp.org).