The Revision Bulletin will be incorporated into USP 38–NF 33
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DEFINITION Norethindrone Acetate and Ethinyl Estradiol Tablets contain NLT 90
Monographs—Small Molecules 4 Expert Committee intends to revise the Norethindrone Acetate and Ethinyl Estradiol Tablets monograph based on a submission from an
The Estradiol and Norethindrone Acetate Tablets Revision Bulletin supersedes the currently official monograph
USP REFERENCE STANDARDS FOR PURCHASE USP Norethindrone Acetate RS USP Monographs, Norethindrone Acetate Tablets
Concomitantly determine the absorbances of this solution and of a Standard solution of USP Norethindrone Acetate RS in alcohol having a known concentration of about 10 µg per mL in 1-cm cells at the wavelength of maximum absorbance at about 240 nm, with a suitable spectrophotometer, using alcohol as the blank
Dissolve an accurately weighed quantity of USP Norethindrone RS in alcohol, and dilute quantitatively and stepwise with alcohol to obtain a Standard solution having a
Norethindrone is also used to treat menstrual disorders, endometriosis, or abnormal vaginal bleeding caused by a hormone imbalance
Apply 20 µL of this test solution and 20 µL of an alcohol solution (Each green tablet contains 1
Mode of Action
The numerical value in µg/g is equivalent to the expression mg/kg and therefore the Expert Committee finds no reason to change it
Effectiveness of progestin-containing hormonal contraceptives and emergency contraceptive ulipristal acetate may be decreased if progestin-containing hormonal contraceptives are used within five days after ulipristal acetate dosing
Identification— Transfer a portion of powdered Tablets, equivalent to about 1 mg of fludrocortisone acetate, to a glass-stoppered, 15-mL centrifuge tube, add 10 mL of acetone, and shake by mechanical means for 3 minutes
USP-NF
Dissolve an accurately weighed quantity of USP Norethindrone Acetate RS in alcohol, and dilute quantitatively
In Test 2/Analysis: Change C S = concentration of USP Norethindrone Acetate RS (mg/mL) or USP Ethinyl Estradiol RS (ug/mL) in the Standard solution to: C S Estradiol and Norethindrone Acetate Tablets USP, 1 mg/0
* USP procures materials worldwide and most foreign materials do not undergo a fundamental change during the packaging process at USP that would substantially transform the item resulting in a country of origin change from the foreign origin to the United States