17b-Hydroxyestr-4-en-3-one hydrocinnamate [62-90-8].
»Nandrolone Phenpropionate contains not less than 97.0percent and not more than 103.0percent of C27H34O3,calculated on the dried basis.
Packaging and storage Preserve in tight,light-resistant containers.
A: Infrared Absorption á197Kñ.
Solution: 10µg per mL.
Absorptivities at 239nm,calculated on the dried basis,do not differ by more than 3.0%.
C: Prepare a solution in acetone containing 5mg per mL.Apply 10µLof this solution and 10µLof a solution of USP Nandrolone Phenpropionate RSin acetone containing 5mg per mLto a suitable thin-layer chromatographic plate (see Chromatography á621ñ)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 n-heptane and acetone (2:1)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 a 1in 50mixture of sulfuric acid in alcohol and heating at 110for 15minutes:the RFvalue of the principal spot obtained from the test solution corresponds to that obtained from the Standard solution.
Melting range á741ñ: between 95and 99.
Specific rotation á781Sñ: between +48and +51.
Test solution: 20mg per mL,in dioxane.
Loss on drying á731ñ Dry it in a suitable vacuum drying tube,using phosphorus pentoxide as the desiccant,at 80for 3hours:it loses not more than 0.5%of its weight.
Organic volatile impurities,Method Vá467ñ: meets the requirements.
Solvent Use dimethyl sulfoxide.
Standard preparation Prepare as directed under Single-Steroid Assay á511ñ,using USP Nandrolone Phenpropionate RS.
Assay preparation Weigh accurately about 20mg of Nandrolone Phenpropionate,previously dried,dissolve it in a sufficient quantity of a mixture of equal volumes of alcohol and chloroform to make 10.0mL,and mix.
Procedure Proceed as directed for Procedureunder Single-Steroid Assay á511ñ,using a solvent system consisting of a mixture of n-heptane and acetone (3:1),through the fourth sentence of the second paragraph under Procedure.Then centrifuge the tubes for 5minutes,and determine the absorbances of the supernatants in 1-cm cells at the wavelength of maximum absorbance at about 239nm,with a suitable spectrophotometer,against the blank.Calculate the quantity,in mg,of C27H34O3in the portion of Nandrolone Phenpropionate taken by the formula:
10C(AU/AS),in which Cis the concentration,in mg per mL,of USP Nandrolone Phenpropionate RSin the Standard preparation,and AUand ASare the absorbances of the solutions from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information Staff Liaison:Clydewyn M.Anthony,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1