Prednisolone Compounded Oral Suspension, Veterinary

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

Prednisolone Compounded Oral Suspension, Veterinary contains NLT 90.0% and NMT 110.0% of the labeled amount of prednisolone (C₂₁H₂₈O₅).

Prepare Prednisolone Compounded Oral Suspension, Veterinary, 20 mg/mL, as follows (see Pharmaceutical Compounding—Nonsterile Preparations 〈795〉).

Pour the weighed Prednisolone powder into a suitable mortar. Wet the powder with a small amount of Purified Water, and triturate to make a smooth paste. Add the Syrup in small portions almost to volume, and mix thoroughly after each addition. Transfer the contents of the mortar stepwise and quantitatively to a calibrated container. Add sufficient Syrup to bring the preparation to final volume. Shake to mix well.

2 ASSAY

2.1 Procedure

Mobile phase: Acetonitrile and water (30:70). Filter, and degas.

System suitability solution: 1 mg/mL of USP Prednisolone RS and 0.06 mg/mL of USP Hydrocortisone RS in Mobile phase

Standard solution: 0.2 mg/mL of prednisolone prepared from USP Prednisolone RS in Mobile phase

Sample solution: Shake thoroughly each bottle of Oral Suspension, Veterinary. Transfer 1.0 mL of the Oral Suspension, Veterinary into a 100-mL volumetric flask, and dilute with Mobile phase to volume to obtain a solution having a nominal concentration of 0.2 mg/mL of prednisolone.

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 246 nm

Column: 4.6-mm × 15-cm; 3-µm packing L1

Column temperature: 40°

Flow rate: 1.0 mL/min

Injection volume: 10 µL

System suitability

Samples: System suitability solution and Standard solution

[Note—The relative retention times for prednisolone and hydrocortisone are about 1.0 and 1.06, respectively.]

Suitability requirements

Resolution: NLT 2.0 between prednisolone and hydrocortisone, System suitability solution

Tailing factor: NMT 2.0, Standard solution

Relative standard deviation: NMT 2.0%, Standard solution

Peak-to-valley ratio: The ratio of the height of the smallest peak to the height of the valley between the prednisolone and hydrocortisone peak is NLT 2, System suitability solution

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of prednisolone (C₂₁H₂₈O₅) in the portion of Oral Suspension, Veterinary taken:

Result = (r_U/r_S) × (C_S/C_U) × 100

r_U = peak response of prednisolone from the Sample solution

r_S = peak response of prednisolone from the Standard solution

C_S = concentration of prednisolone in the Standard solution (mg/mL)

C_U = nominal concentration of prednisolone in the Sample solution (mg/mL)

Acceptance criteria: 90.0%–110.0% 

3 SPECIFIC TESTS

pH 〈791〉: 2.6–3.6

4 ADDITIONAL REQUIREMENTS

Packaging and Storage: Package in tight, light-resistant containers. Store at 2°–8° or at controlled room temperature.

Labeling: Label it to indicate that it is to be well-shaken before use, and to state the Beyond-Use Date. Label it to state that it is for veterinary use only.

Beyond-Use Date: NMT 90 days after the date on which it was compounded when stored at 2°–8° or at controlled room temperature

USP Reference Standards 〈11〉

USP Hydrocortisone RS

USP Prednisolone RS