Ethynodiol Diacetate and Ethinyl Estradiol Tablets
DEFINITION
Ethynodiol Diacetate and Ethinyl Estradiol Tablets contain NLT 93.0% and NMT 107.0% of the labeled amount of ethynodiol diacetate (C24H32O4), and NLT 90.0% and NMT 110.0% of the labeled amount of ethinyl estradiol (C20H24O2).
IDENTIFICATION
• Thin Layer Chromatographic Identification Test 
201
201
The retention times of the ethynodiol diacetate and ethinyl estradiol peaks from the Sample solution correspond to those from the Standard solution, as obtained in the Assay.
ASSAY
• Procedure
Mobile phase:
Methanol, acetonitrile, and water (3:7:10)
Standard solution:
Dissolve, with the aid of sonication if necessary, quantities of USP Ethynodiol Diacetate RS and USP Ethinyl Estradiol RS in Mobile phase. Dilute quantitatively, and stepwise if necessary, with Mobile phase to obtain a solution having known concentrations, in mg/mL, of the Reference Standards, corresponding to about 1/25 of the labeled amounts of ethynodiol diacetate and ethinyl estradiol in the Tablets.
Sample solution:
Place 10 Tablets in a 250-mL volumetric flask. Add a portion of Mobile phase, and sonicate until the Tablets are completely disintegrated. Cool to room temperature, dilute with Mobile phase to volume, and filter.
Chromatographic system
Mode:
LC
Detector:
UV 210 nm
Column:
4.6-mm × 25-cm; packing L10
Flow rate:
2 mL/min
Injection size:
50 µL
System suitability
Sample:
Standard solution
Suitability requirements
Column efficiency:
NLT 3000 theoretical plates for ethynodiol diacetate
Tailing factor:
NMT 1.5 for ethynodiol diacetate
Relative standard deviation:
NMT 2.0% for each peak due to ethynodiol diacetate and ethinyl estradiol
Analysis
Samples:
Standard solution and Sample solution
Calculate the percentage of C24H32O4 in each Tablet taken:
Result = (rU/rS) × (CS/CU) × 100
| rU | = | = peak response of ethynodiol diacetate from the Sample solution |
| rS | = | = peak response of ethynodiol diacetate from the Standard solution |
| CS | = | = concentration of USP Ethynodiol Diacetate RS in the Standard solution (mg/mL) |
| CU | = | = nominal concentration of ethynodiol diacetate in the Sample solution |
Calculate the percentage of C20H24O2 in each Tablet taken:
Result = (rU/rS) × (CS/CU) × 100
| rU | = | = peak response of ethinyl estradiol from the Sample solution |
| rS | = | = peak response of ethinyl estradiol from the Standard solution |
| CS | = | = concentration of USP Ethinyl Estradiol RS in the Standard solution (mg/mL) |
| CU | = | = nominal concentration of ethinyl estradiol in the Sample solution |
Acceptance criteria:
93.0%–107.0% of the labeled amount of C24H32O4 and 90.0%–110.0% of the labeled amount of C20H24O2
PERFORMANCE TESTS
• Disintegration 701:
15 min, the use of disks being omitted
701:
15 min, the use of disks being omitted
• Uniformity of Dosage Units 905:
Meet the requirements for Content Uniformity with respect to ethynodiol diacetate and to ethinyl estradiol
905:
Meet the requirements for Content Uniformity with respect to ethynodiol diacetate and to ethinyl estradiol
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in well-closed containers.
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Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Domenick Vicchio, Ph.D.
Senior Scientific Liaison 1-301-998-6828 |
(SM42010) Monographs - Small Molecules 4 |
| 701 |
Margareth R.C. Marques, Ph.D.
Senior Scientific Liaison 1-301-816-8106 |
(GCDF2010) General Chapters - Dosage Forms |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 3136
Pharmacopeial Forum: Volume No. 36(5) Page 1179