Prednisolone Acetate Injectable Suspension

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

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

DOWNLOAD PDF HERE

1 DEFINITION

Prednisolone Acetate Injectable Suspension is a sterile suspension of Prednisolone Acetate in a suitable aqueous medium. It contains NLT 90.0% and NMT 110.0% of the labeled amount of prednisolone acetate (C₂₃H₃₀O₆).

2 IDENTIFICATION

A. Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197K

Sample: Allow a volume of Injectable Suspension equivalent to 50 mg of prednisolone acetate to settle. Decant and discard the supernatant. Dissolve the residue in 6 mL of alcohol. Evaporate the resulting solution, with the aid of a current of air, to half its volume, when crystallization occurs. Chill, if necessary, to aid crystallization. Filter the crystals, and allow to dry with the aid of a current of air. Use the crystals.

Acceptance criteria: Meets the requirements

Add the following:

B. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay. (USP 1-Aug-2020)

3 ASSAY

Change to read:

3.1 Procedure

Mobile phase: Acetonitrile and water (40:60)

Diluent: Methanol and acetonitrile (50:50)

Standard solution: 0.1 mg/mL of USP Prednisolone Acetate RS in Diluent

Sample solution: Nominally 0.1 mg/mL of prednisolone acetate, from a volume of Injectable Suspension, in Diluent

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 254 nm

Column: 4.6-mm × 25-cm; 5-µm (USP 1-Aug-2020) packing L1

Flow rate: 1 mL/min

Injection volume: 10 µL

Run time: NLT 2 times the retention time of prednisolone acetate (USP 1-Aug-2020)

System suitability

Sample: Standard solution

Suitability requirements

Capacity factor, k′: NLT 3.0

Relative standard deviation: NMT 3.0%

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of prednisolone acetate (C₂₃H₃₀O₆) in each milliliter of Injectable Suspension taken:

Result = (r_U/r_S) × (C_S/C_U) × 100

r_U = peak response of prednisolone acetate from the Sample solution

r_S = peak response of prednisolone acetate from the Standard solution

C_S = concentration of USP Prednisolone Acetate RS in the Standard solution (mg/mL)

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

Acceptance criteria: 90.0%–110.0%

4 SPECIFIC TESTS

Add the following:

Bacterial Endotoxins Test 〈85〉: Meets the requirements (USP 1-Aug-2020)

pH 〈791〉: 5.0–7.5

Add the following:

Sterility Tests 〈71〉: Meets the requirements (USP 1-Aug-2020)

Other Requirements: It meets the requirements under Injections and Implanted Drug Products 〈1〉.

5 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in single-dose or in multiple-dose containers, preferably of Type I glass.

USP Reference Standards 〈11〉

USP Prednisolone Acetate RS