Meprednisone
;)
Pregna-1,4-diene-3,11,20-trione,17,21-dihydroxy-16-methyl-,(16b)-.
17,21-Dihydroxy-16b-methylpregna-1,4-diene-3,11,20-trione [1247-42-3].
»Meprednisone contains not less than 97.5percent and not more than 102.5percent of C22H28O5,calculated on the dried basis.
Packaging and storage—
Preserve in tight,light-resistant containers,and avoid exposure to excessive heat.
Identification—
A:
Infrared Absorption á197Mñ.
B:
Ultraviolet Absorption á197Uñ—
Solution:
10µg per mL.
Medium:
methanol.
Absorptivities at 238nm,calculated on the dried basis,do not differ by more than 3.0%.
C:
Thin-Layer Chromatographic Identification Test á201ñ—
Test solution:
20mg per mL,in a mixture of toluene and alcohol (1:1).
Spray reagent:
10%(v/v)sulfuric acid in alcohol solution.
Procedure—
Proceed as directed in the chapter.Locate the spots on the plate by spraying with Spray reagentand heating at 105
for 10minutes.
for 10minutes.
Specific rotation á781Sñ:
between +180and +188.
and +188.
Test solution:
10mg per mL,in dioxane.
Loss on drying á731ñ—
Dry it at 105for 3hours:it loses not more than 1.0%of its weight.
for 3hours:it loses not more than 1.0%of its weight.
Residue on ignition á281ñ:
not more than 0.1%.
Assay—
Standard preparation—
Prepare as directed under Single-Steroid Assay á511ñ,using USP Meprednisone RS.
Assay preparation—
Accurately weigh about 20mg of Meprednisone,previously dried,dissolve it in a sufficient quantity of a mixture of alcohol and chloroform (1:1)to make 10.0mL,and mix.
Procedure—
Proceed as directed for Procedureunder Single-Steroid Assay á511ñ,using a solvent system consisting of chloroform,methanol,and water (180:15:1),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 238nm,with a suitable spectrophotometer,against the blank.Calculate the quantity,in mg,of C22H28O5in the portion of Meprednisone taken by the formula:
10C(AU/AS),
in which Cis the concentration,in mg per mL,of USP Meprednisone 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 1213
Pharmacopeial Forum:Volume No.27(2)Page 2174
Phone Number:1-301-816-8139