Prednisone Tablets
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This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
1 DEFINITION
Prednisone Tablets contain NLT 90.0% and NMT 110.0% of the labeled amount of prednisone (C₂₁H₂₆O₅).
2 IDENTIFICATION
A. Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197K
Sample: Nominally 10 mg of prednisone from pulverized Tablets
Analysis: Place the Sample in a 50-mL beaker, 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 absorb for 10 min. Elute the column with 60 mL of water-washed ether, and 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 min.
Acceptance criteria: The crystals meet the requirements. If a difference appears, dissolve portions of both the crystals and the Reference Standard in methanol, evaporate the solutions to dryness, and repeat the tests.
B.
Analysis 1: Dissolve 6 mg of the crystals obtained in Identification test A in 2 mL of sulfuric acid, and allow to stand for 5 min.
Acceptance criteria 1: An orange color is produced.
Analysis 2: Pour the resulting solution from Analysis 1 into 10 mL of water.
Acceptance criteria 2: The color changes first to yellow and then, gradually, to bluish green.
3 ASSAY
Procedure
Mobile phase: Peroxide-free tetrahydrofuran, methanol, and water (250:62:688). Prepare the Mobile phase such that, at a flow rate of 1.0 mL/min, the retention times of prednisone and acetanilide are about 8 and 6 min, respectively.
Diluent: Methanol and water (1:1)
Internal standard solution: 110 µg/mL of acetanilide in Diluent
Standard stock solution: 0.2 mg/mL of USP Prednisone RS in Diluent
Standard solution: 20 µg/mL of USP Prednisone RS and 11 µg/mL of acetanilide in Diluent from the Standard stock solution and the Internal standard solution, respectively. Prepare this solution fresh.
Sample stock solution: Nominally 0.2 mg/mL of prednisone prepared as follows. Transfer an amount of powder equivalent to 20 mg of prednisone from NLT 20 powdered Tablets to a suitable volumetric flask. Add 5% of the flask volume of water, and sonicate for 1 min. Add 50% of the flask volume of methanol, and sonicate again for 1 min. Dilute with water to volume.
Sample solution: Nominally 20 µg/mL of prednisone and 11 µg/mL of acetanilide in Diluent from the Sample stock solution and the Internal standard solution, respectively. Pass through a suitable filter of 5-µm pore size, discarding the first 20 mL of the filtrate.
Chromatographic system
(See Chromatography 〈621〉, System Suitability.)
Mode: LC
Detector: UV 254 nm
Column: 4-mm × 25-cm; packing L1
Injection volume: 10 µL
System suitability
Sample: Standard solution
Suitability requirements
Resolution: NLT 3 between prednisone and acetanilide
Relative standard deviation: NMT 2.0%
Analysis
Samples: Standard solution and Sample solution
Calculate the percentage of the labeled amount of prednisone (C₂₁H₂₆O₅) in the portion of Tablets taken:
Result = (Rᵤ / Rₛ) × (Cₛ / Cᵤ) × 100
Rᵤ = peak response ratio of prednisone to acetanilide from the Sample solution
Rₛ = peak response ratio of prednisone to acetanilide from the Standard solution
Cₛ = concentration of USP Prednisone RS in the Standard solution (µg/mL)
Cᵤ = nominal concentration of prednisone in the Sample solution (µg/mL)
Acceptance criteria: 90.0%–110.0%
4 PERFORMANCE TESTS
Dissolution 〈711〉
Test 1
Medium: Water; use 500 mL of the 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 min
Standard solution: USP Prednisone RS in Medium.
[Note—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 before dilution with Medium.]
Sample solution: Pass a portion of the solution under test through a suitable filter, and dilute with Medium, if necessary, to a concentration that is similar to the Standard solution.
Instrumental conditions
Mode: UV
Analytical wavelength: Maximum at about 242 nm
Tolerances: NLT 80% (Q) of the labeled amount of prednisone (C₂₁H₂₆O₅) is dissolved.
Test 2: If the product complies with this test, the labeling indicates that it meets USP Dissolution Test 2.
[Note—Protect solutions containing prednisone from light.]
Medium: 0.1 N hydrochloric acid; 500 mL
Apparatus 2: 75 rpm
Time: 30 min
Diluted phosphoric acid: Dilute 10 mL of phosphoric acid with water to 100 mL.
Buffer: Add 1.0 mL of triethylamine to 1000 mL of water and adjust with Diluted phosphoric acid to a pH of 5.2.
Mobile phase: Acetonitrile and Buffer (40:60)
Standard stock solution: 0.25 mg/mL of USP Prednisone RS prepared as follows. Transfer an appropriate amount of USP Prednisone RS to a suitable volumetric flask. Add 25% of the flask volume of acetonitrile and sonicate to dissolve. Dilute with water to volume.
Standard solution: (L/500) mg/mL of USP Prednisone RS from Standard stock solution in Medium, where L is the label claim in mg/Tablet. For Tablets of 20 mg strength, use (L/1000) mg/mL.
Sample solution: Pass a portion of the solution under test through a suitable filter of 0.45-µm pore size, discarding the first 2 mL of the filtrate. Dilute with Medium, if necessary.
Chromatographic system
(See Chromatography 〈621〉, System Suitability.)
Mode: LC
Detector: UV 242 nm
Column: 4.6-mm × 25-cm; 5-µm packing L1
Column temperature: 35°
Flow rate: 1.5 mL/min
Injection volume: 100 µL
Run time: NLT 1.7 times the retention time of prednisone
System suitability
Sample: Standard solution
Suitability requirements
Tailing factor: NMT 2.0
Relative standard deviation: NMT 2.0%
Analysis
Samples: Standard solution and Sample solution
Calculate the percentage of the labeled amount of prednisone (C₂₁H₂₆O₅) dissolved:
Result = (rᵤ / rₛ) × C × D × V × (1/L) × 100
rᵤ = peak response of prednisone from the Sample solution
rₛ = peak response of prednisone from the Standard solution
C = concentration of USP Prednisone RS in the Standard solution (mg/mL)
D = dilution factor, if necessary
V = volume of Medium, 500 mL
L = label claim (mg/Tablet)
Tolerances: NLT 80% (Q) of the labeled amount of prednisone (C₂₁H₂₆O₅) is dissolved.
Change to read:
Uniformity of Dosage Units 〈905〉: ▲Meet the requirements▲ (CN 1-Aug-2023)
Procedure for content uniformity
Mobile phase, Diluent, Internal standard solution, Standard stock solution, Standard solution, and Chromatographic system: Proceed as directed in the Assay.
Sample stock solution: Place 1 Tablet in a suitable volumetric flask that when the contents are diluted to volume, the resulting solution has a nominal concentration of 0.2 mg/mL of prednisone. Add 5 mL of water, swirl, sonicate for 1 min, add a volume of methanol equal to one-half the volume of the volumetric flask, and sonicate again for 1 min. Dilute with water to volume.
Sample solution: Nominally 20 µg/mL of prednisone and 11 µg/mL of acetanilide in Diluent from the Sample stock solution and the Internal standard solution, respectively. Pass through a suitable filter of 5-µm pore size, discarding the first 20 mL of the filtrate.
Analysis
Samples: Standard solution and Sample solution
Calculate the percentage of the labeled amount of prednisone (C₂₁H₂₆O₅) in the Tablet taken:
Result = (Rᵤ / Rₛ) × (Cₛ / Cᵤ) × 100
Rᵤ = peak response ratio of prednisone to acetanilide from the Sample solution
Rₛ = peak response ratio of prednisone to acetanilide from the Standard solution
Cₛ = concentration of USP Prednisone RS in the Standard solution (µg/mL)
Cᵤ = nominal concentration of prednisone in the Sample solution (µg/mL)
▲ (CN 1-Aug-2023)
5 ADDITIONAL REQUIREMENTS
Packaging and Storage: Preserve in well-closed containers.
Labeling: When more than one Dissolution test is given, the labeling states the Dissolution test used only if Test 1 is not used.
USP Reference Standards 〈11〉
USP Prednisone RS
