Fluorometholone Ophthalmic Suspension

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

Fluorometholone Ophthalmic Suspension is a sterile suspension of Fluorometholone in a suitable aqueous medium. It contains NLT 90.0% and NMT 110.0% of the labeled amount of fluorometholone (C₂₂H₂₉FO₄). It may contain suitable stabilizers, buffers, and antimicrobial agents.

2 IDENTIFICATION

Change to read:

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

Sample: Shake a quantity of Ophthalmic Suspension, nominally equivalent to 5 mg of fluorometholone, with 20 mL of acetone. Filter, and evaporate the filtrate to dryness. Dissolve the residue in 10 mL of acetone, filter, and evaporate the filtrate to dryness.

Acceptance criteria: Meets the requirements

B. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.

3 ASSAY

3.1 Procedure

Mobile phase: Methanol and water (60:40)

Diluent: Methanol and water (1:1)

System suitability solution: 0.5 μg/mL each of USP Fluorometholone RS and USP Fluorometholone Related Compound A RS in Diluent

Standard stock solution: 0.5 mg/mL of USP Fluorometholone RS in methanol

Standard solution: 40 μg/mL of USP Fluorometholone RS in Diluent, from Standard stock solution

Sample solution: Nominally equivalent to 40 μg/mL of fluorometholone in Diluent prepared from a suitable quantity of well-shaken Ophthalmic Suspension

3.2 Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 254 nm

Column: 3.9-mm × 30-cm; 10-μm packing L1

Flow rate: 2 mL/min

Injection volume: 20 μL

3.3 System suitability

Samples: System suitability solution and Standard solution

3.4 Suitability requirements

Resolution: NLT 1.5 between fluorometholone and fluorometholone related compound A, System suitability solution

Relative standard deviation: NMT 2.0%, Standard solution

3.5 Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of fluorometholone (C₂₂H₂₉FO₄) in the portion of Ophthalmic Suspension 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 Fluorometholone RS in the Standard solution (μg/mL)

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

Acceptance criteria: 90.0%–110.0%

4 IMPURITIES

4.1 Organic Impurities

Mobile phase, Diluent, System suitability solution, and Chromatographic system: Proceed as directed in the Assay.

Standard solution: 0.5 μg/mL of USP Fluorometholone RS in Diluent

Sample solution: Nominally equivalent to 100 μg/mL of fluorometholone in Diluent prepared from a suitable quantity of Ophthalmic Suspension

4.2 System suitability

Samples: System suitability solution and Standard solution

4.3 Suitability requirements

Resolution: NLT 1.5 between fluorometholone and fluorometholone related compound A, System suitability solution

Relative standard deviation: NMT 10.0%, Standard solution

4.4 Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of each impurity in the portion of Ophthalmic Suspension taken:

Result = (r_U/r_S) × (C_S/C_U) × 100

r_U = peak response for each impurity from the Sample solution

r_S = peak response of fluorometholone from the Standard solution

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

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

4.5 Acceptance criteria

Each impurity: NMT 0.5%

Total impurities: NMT 1%

5 SPECIFIC TESTS

Sterility Tests 〈71〉: Meets the requirements

pH 〈791〉: 6.0–7.5

6 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in tight containers.

USP Reference Standards 〈11〉

USP Fluorometholone RS

USP Fluorometholone Related Compound A RS

11β,17α-Dihydroxy-6α-methylpregna-1,4-diene-3,20-dione.

C₂₂H₃₀O₄ 358.47