NOTICE OF POSTPONEMENT

USP Issues Postponement for Norgestimate and Ethinyl Estradiol Tablets Monograph Effective August 1, 2007


August 1, 2007

The test for Chromatographic purity in the Norgestimate and Ethinyl Estradiol Tablets monograph is revised as shown  (23KB) because the control of the norgestrel acetate impurity from Norgestimate was 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.

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.