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Oxandrolone
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C19H30O3 306.44

2-Oxaandrostan-3-one, 17-hydroxy-17-methyl-, (5,17)-.
17-Hydroxy-17-methyl-2-oxa-5-androstan-3-one [53-39-4].
» Oxandrolone contains not less than 97.0 percent and not more than 100.5 percent of C19H30O3, calculated on the dried basis.
Packaging and storage— Preserve in well-closed, light-resistant containers.
Identification—
B: Prepare a solution in chloroform containing 5 mg per mL. Apply 10 µL each of this solution and a solution of USP Oxandrolone RS in chloroform, containing 5 mg per mL to a suitable thin-layer chromatographic plate (see Chromatography 621) coated with a 0.25-mm layer of chromatographic silica gel. Allow the spots to dry, and develop the chromatogram in a solvent system consisting of a mixture of chloroform and methanol (19:1) until the solvent front has moved about three-fourths of the length of the plate. Remove the plate from the developing chamber, mark the solvent front, and allow the solvent to evaporate. Locate the spots on the plate by lightly spraying with dilute sulfuric acid (1 in 2) and heating on a hot plate or under a lamp until spots appear: the RF value of the principal spot obtained from the test solution corresponds to that obtained from the Standard solution.
Specific rotation 781S: between 18 and 24.
Test solution: 10 mg per mL, in chloroform.
Loss on drying 731— Dry it at 105 for 3 hours: it loses not more than 1.0% of its weight.
Residue on ignition 281: not more than 0.2%.
Ordinary impurities 466—
Test solution: methanol.
Standard solution: methanol.
Application volume: 10 µL.
Eluant: a mixture of toluene and isopropyl alcohol (90:10), in a nonequilibrated chamber.
Visualization: 5.
Organic volatile impurities, Method V 467: meets the requirements.
Solvent— Use dimethyl sulfoxide.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay— Transfer about 500 mg of Oxandrolone, accurately weighed, to a 250-mL conical flask, and add 25.0 mL of 0.1 N alcoholic potassium hydroxide VS. Insert into the neck of the flask, by means of a perforated stopper, an air condenser consisting of a glass tube 70 to 80 cm in length and 5 to 8 mm in diameter, and heat the flask on a steam bath for 30 minutes, frequently rotating the contents. Cool, add 1 mL of phenolphthalein TS, and titrate the excess alkali with 0.1 N hydrochloric acid VS. Perform a blank determination, and make any necessary correction. Each mL of 0.1 N alcoholic potassium hydroxide is equivalent to 30.64 mg of C19H30O3.
Auxiliary Information— Staff Liaison : Daniel K. Bempong, Ph.D., Scientist
Expert Committee : (MDPS05) Monograph Development-Pulmonary and Steroids
USP29–NF24 Page 1591
Pharmacopeial Forum : Volume No. 31(1) Page 64
Phone Number : 1-301-816-8143