Prednisone Tablets
» Prednisone Tablets contain not less than 90.0 percent and not more than 110.0 percent of the labeled amount of C21H26O5.
Packaging and storage— Preserve in well-closed containers.
USP Reference standards 11
USP Prednisone RS Click to View Structure
Identification— Into a 50-mL beaker containing a portion of pulverized Tablets, equivalent to about 10 mg of prednisone, add 10 mL of water, and mix to form a slurry. Transfer the slurry to a 3-cm × 13-cm column packed with diatomaceous earth, and allow to be absorbed for a period of 10 minutes. Elute the column with 60 mL of water-washed ether, evaporate the eluate on a steam bath to dryness, wash the residue with three 20-mL portions of n-heptane, and filter. Dry the residue at 105 for 30 minutes: the crystals respond to Identification tests A and B under Prednisone.
Dissolution 711
Medium: water; use 500 mL of the Dissolution Medium for Tablets labeled to contain 10 mg of prednisone or less, and 900 mL for Tablets labeled to contain more than 10 mg of prednisone.
Apparatus 2: 50 rpm.
Time: 30 minutes.
Procedure— Determine the amount of C21H26O5 dissolved from UV absorbances at the wavelength of maximum absorbance at about 242 nm of filtered portions of the solution under test, suitably diluted with Dissolution Medium, if necessary, in comparison with a Standard solution having a known concentration of USP Prednisone RS in the same medium. An amount of alcohol not to exceed 5% of the total volume of the Standard solution may be used to bring the prednisone standard into solution prior to dilution with water.
Tolerances— Not less than 80% (Q) of the labeled amount of C21H26O5 is dissolved in 30 minutes.
Uniformity of dosage units 905: meet the requirements.
Procedure for content uniformity—
Mobile phase, Internal standard solution, Standard preparation, and Chromatographic system— Proceed as directed in the Assay under Prednisone.
Test preparation— Place 1 Tablet in a volumetric flask of such size that when the contents are diluted to volume the resulting solution has a concentration of about 0.2 mg of prednisone per mL. Add 5 mL of water, swirl, sonicate for 1 minute, add a volume of methanol equal to one-half the volume of the volumetric flask, and sonicate again for 1 minute. Dilute with water to volume, and mix. Transfer 5.0 mL of this solution and 5.0 mL of the Internal standard solution to a 50-mL volumetric flask, add dilute methanol (1 in 2) to volume, and mix. Filter through a 5-µm filter, discarding the first 20 mL of the filtrate.
Procedure— Proceed as directed for Procedure in the Assay under Prednisone, except to calculate the quantity, in mg, of C21H26O5 in the Tablet taken by the formula:
DC(RU / RS)
in which D is the dilution factor for the Test preparation and the other terms are as defined therein.
Assay—
Mobile phase, Internal standard solution, Standard preparation, and Chromatographic system— Proceed as directed in the Assay under Prednisone.
Assay preparation— Weigh and finely powder not less than 20 Tablets. Transfer an accurately weighed portion of the powder, equivalent to about 20 mg of prednisone, to a 100-mL volumetric flask. Add 5 mL of water, sonicate for 1 minute, add 50 mL of methanol, and sonicate again for 1 minute. Dilute with water to volume, and mix. Transfer 5.0 mL of this solution and 5.0 mL of the Internal standard solution to a 50-mL volumetric flask, add dilute methanol (1 in 2) to volume, and mix. Filter through a 5-µm filter, discarding the first 20 mL of the filtrate.
Procedure— Proceed as directed for Procedure in the Assay under Prednisone, except to calculate the quantity, in mg, of C21H26O5 in the portion of Tablets taken by the formula:
C(RU / RS)
in which the terms are as defined therein.
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