Norethynodrel
19-Norpregn-5(10)-en-20-yn-3-one, 17-hydroxy-, (17 ![]() 17-Hydroxy-19-nor-17 ![]() ![]() ![]() ![]() » Norethynodrel contains not less than 97.0 percent and not more than 101.0 percent of C20H26O2.
Packaging and storage
Preserve in well-closed containers.
Limit of ethynyl group
Dissolve 200 mg in about 40 mL of tetrahydrofuran. Add 10 mL of silver nitrate solution (1 in 10), and titrate with 0.1 N sodium hydroxide VS, using either a glass-calomel or a silver-silver chloride electrode system with potassium nitrate filling solution. Each mL of 0.1 N sodium hydroxide is equivalent to 2.503 mg of ethynyl group (C
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Limit of norethindrone
Test preparation
Prepare a solution of Norethynodrel in chloroform containing 10 mg per mL.
Standard solution
Prepare a solution of USP Norethindrone RS in chloroform to contain 1 mg per mL. Dilute 2 mL of the solution with chloroform to 10 mL.
Procedure
Apply 10-µL volumes of the Test preparation and the Standard solution (see Chromatography
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Ordinary impurities
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Test solution:
chloroform.
Standard solution:
chloroform.
Eluant:
ether.
Visualization:
5, followed by viewing under long-wavelength UV light.
Assay
Standard preparation
Dissolve a suitable quantity of USP Norethynodrel RS, accurately weighed, in methanol, and dilute quantitatively with methanol to obtain a solution having a known concentration of about 1 mg per mL.
Assay preparation
Dissolve about 100 mg of Norethynodrel, accurately weighed, in methanol to make 100.0 mL, and mix.
Procedure
Transfer 10.0 mL each of the Standard preparation and the Assay preparation to separate 100-mL volumetric flasks. To each flask add 40 mL of methanol, then add 5 mL of a mixture of 3 volumes of hydrochloric acid and 2 volumes of water, mix quickly, and allow to stand at a temperature of about 25
![]() 100C(AU / AS)
in which C is the concentration, in mg per mL, of USP Norethynodrel RS in the Standard preparation, and AU and AS are the absorbances of the solutions from the Assay preparation and the Standard preparation, respectively.
Auxiliary Information
Please check for your question in the FAQs before contacting USP.
Chromatographic Column
USP32NF27 Page 3111
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.
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