Oxymetholone
;)
Androstan-3-one,17-hydroxy-2-(hydroxymethylene)-17-methyl-,(5a,17b)-.
17b-Hydroxy-2-(hydroxymethylene)-17-methyl-5a-androstan-3-one [434-07-1].
»Oxymetholone contains not less than 97.0percent and not more than 103.0percent of C21H32O3,calculated on the dried basis.
Packaging and storage—
Preserve in well-closed containers.
Completeness of solution—
Dissolve 100mg in 5mLof dioxane:the solution is clear and free from undissolved solid.
Identification—
A:
Infrared Absorption á197Kñ.
Solution:
10µg per mL.
Medium:
0.01Nmethanolic sodium hydroxide.
Specific rotation á781Sñ:
between +34
and +38.
and +38.
Test solution:
20mg per mL,in dioxane.
Loss on drying á731ñ—
Dry it in vacuum over phosphorus pentoxide for 4hours:it loses not more than 1.0%of its weight.
Organic volatile impurities,Method Vá467ñ:
meets the requirements.
Solvent—
Use dimethyl sulfoxide.
Assay—
Standard preparation—
Prepare as directed under Single-steroid Assay á511ñ,using USP Oxymetholone RS.
Assay preparation—
Weigh accurately about 20mg of Oxymetholone,previously dried,dissolve 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 benzene and alcohol (98:2),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 315nm,with a suitable spectrophotometer,against the blank.[NOTE—Use 0.01Nalcoholic sodium hydroxide,rather than alcohol,to elute the silica gel bands.]Calculate the quantity,in mg,of C21H32O3in the portion of Oxymetholone taken by the formula:
10C(AU/AS),
in which Cis the concentration,in mg per mL,of USP Oxymetholone 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
USP28–NF23Page 1445
Phone Number:1-301-816-8139