C21H28O2 312.45

18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17)-()-.
()-13-Ethyl-17-hydroxy-18,19-dinor-17-pregn-4-en-20-yn-3-one [797-63-7].

Packaging and storage— Preserve in well-closed, light-resistant containers.

USP Reference standards 11— USP Norgestrel RS.

Identification—

Melting range 741: between 232 and 239, but the range between beginning and end of melting does not exceed 4.

Specific rotation 781S: between 30 and 35.

Loss on drying 731— Dry it at 105 for 5 hours: it loses not more than 0.5% of its weight.

Residue on ignition 281: not more than 0.3%.

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. Perform a blank determination, and make any necessary correction. Each mL of 0.1 N sodium hydroxide is equivalent to 2.503 mg of ethynyl group (-CCH). Not less than 7.81% and not more than 8.18% of ethynyl group is found.

Chromatographic purity— Proceed as directed in the test for Chromatographic purity under Norgestrel. The requirements of the test are met if the sum of the impurities in the Test preparation does not exceed 2.0% and no single impurity is greater than 0.5%.

Residual solvents 467: meets the requirements.

Assay— Using USP Norgestrel RS, proceed with Levonorgestrel as directed in the Assay under Norgestrel, except to read “Levonorgestrel” in place of “Norgestrel.”

Expert Committee : (MDPS05) Monograph Development-Pulmonary and Steroids

USP29–NF24 Page 1245

Phone Number : 1-301-816-8143