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NOTICE OF POSTPONEMENTUSP Issues Postponement for Norgestimate and Ethinyl Estradiol Tablets Monograph Effective August 1, 2007August 1, 2007 The test for Chromatographic purity in the Norgestimate and Ethinyl Estradiol Tablets monograph is revised as shown 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. Please direct any comments or questions related to the Chromatographic purity test to Daniel Bempong, Ph.D., Senior Scientist (301-816-8143 or ). Please direct any comments or questions related to the Dissolution test to Margareth Marques, Ph.D., Senior Scientist (301-816-8106 or ). Data for these tests must be submitted by October 1, 2007 to ensure consideration. |
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