Prednisone Oral Solution

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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1 DEFINITION

Prednisone Oral Solution contains NLT 90.0% and NMT 110.0% of the labeled amount of prednisone (C₂₁H₂₆O₅).

2 IDENTIFICATION

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A. Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197K (CN 1-May-2020)

Sample: 50 mL of Oral Solution

Analysis: Shake the Sample with 25 mL of chloroform for 5 min. Filter the chloroform extract through a pledget of cotton and a layer of anhydrous sodium sulfate, and evaporate on a warm water bath with the aid of a current of air to 3 mL. Continue the evaporation to dryness at room temperature. Wash the residue with two 10-mL portions of hot solvent hexane, decanting the solvent and discarding it each time. Digest the residue with 25 mL of warm dehydrated alcohol for 15 min. Filter the mixture, and evaporate the filtrate to 3 mL. Add solvent hexane until the mixture becomes slightly cloudy, and chill in a freezer to promote the formation of crystals. Collect the crystals, and dry at 60° for 1 h.

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.

3 ASSAY

3.1 Procedure

Mobile phase: Dissolve 1.36 g of monobasic sodium phosphate in 600 mL of water. To this solution add 400 mL of methanol.

Standard stock solution: 1 mg/mL of USP Prednisone RS in alcohol

Standard solution: 40 µg/mL of USP Prednisone RS in water from the Standard stock solution

Sample solution: Nominally 40 µg/mL of prednisone in water from a measured volume of Oral Solution

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 254 nm

Column: 3.9-mm × 30-cm; packing L1

Flow rate: 1.5 mL/min

Injection volume: 10 µL

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) in the portion of Oral Solution taken:

Result = (r_U/r_S) × (C_S/C_U) × 100

r_U = peak response from the Sample solution

r_S = peak response from the Standard solution

C_S = concentration of USP Prednisone RS in the Standard solution (µg/mL)

C_U = nominal concentration of prednisone in the Sample solution (µg/mL)

Acceptance criteria: 90.0%–110.0%

4 OTHER COMPONENTS

Alcohol Determination, Method II 〈611〉: 2.0%–6.0%

5 PERFORMANCE TESTS

Uniformity of Dosage Units 〈905〉

For single-unit containers

Acceptance criteria: Meets the requirements

Deliverable Volume 〈698〉

For multiple-unit containers

Acceptance criteria: Meets the requirements

6 SPECIFIC TESTS

pH 〈791〉: 2.6–4.5

7 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in tight containers.

USP Reference Standards 〈11〉

USP Prednisone RS