Voriconazole Compounded Ophthalmic Solution, 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

Voriconazole Compounded Ophthalmic Solution, Veterinary contains NLT 90.0% and NMT 110.0% of the labeled amount of voriconazole (C₁₆H₁₄F₃N₅O).

Prepare Voriconazole Compounded Ophthalmic Solution, Veterinary 10 mg/mL as follows (see Pharmaceutical Compounding-Sterile Preparations (797)).

^a V-Fend 200-mg injection, Pfizer, Inc., Groton, CT.

Reconstitute Voriconazole for Injection with Sodium Chloride Injection (0.9%) to bring to a final volume of 20 mL. [NOTE-May reconstitute

according to package insert to achieve a 10-mg/mL solution.] Shake well until a clear solution is achieved. Aseptically draw up into sterile unit-dose 1-mL. syringes.

2 ASSAY

PROCEDURE

Solution A: 30 mM monobasic sodium phosphate adjusted with phosphoric acid to a pH of 4.0

Mobile phase: Methanol, acetonitrile, and Solution A (30:15:55). Pass through a PTFE filter of 0.45-µm pore size.

Standard solution: 0.25 mg/mL of voriconazole prepared from USP Voriconazole RS in Mobile phase. Sonicate for about 5 min to dissolve.

Sample solution: Transfer 250 µL of Ophthalmic Solution, Veterinary into a 10-mL volumetric flask, dilute with Mobile phase to volume, and mix well to dissolve. Protect from light.

Chromatographic system

(See Chromatography (621), System Suitability.)

Mode: LC

Detector: UV 256 nm

Column: 3.9-mm x 15-cm; 5-µm packing L1

Column temperature: 30°

Flow rate: 1.0 mL/min

Injection volume: 10 µL

System suitability

Sample: Standard solution

[NOTE-The retention time for voriconazole is about 4.2 min.]

Suitability requirements

Tailing factor: NMT 2.0

Relative standard deviation: NMT 2.0% for replicate injections

Analysis

Samples: Standard solution and Sample solution Calculate the percentage of the labeled amount of voriconazole (C₁₆H₁₄F₃N₅O) in the portion of Ophthalmic Solution, Veterinary taken:

                         Result = (r_U/r_S) × (C_S/C_U) × 100

r_U = peak response of voriconazole from the Sample solution 

r_S = peak response of voriconazole from the Standard solution 

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

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

Acceptance criteria: 90.0%-110.0%

3 SPECIFIC TESTS

pH (791): 5.7-6.7

STERILITY TESTS (71): It meets the requirements when tested as directed in Test for Sterility of the Product to be Examined, Membrane Filtration.

Change to read:

^▲SUBVISIBLE PARTICULATE MATTER IN INTRAOCULAR SOLUTIONS (789) _{▲(CN 1-MAY-2024)}: It meets the requirements.

4 ADDITIONAL REQUIREMENTS

PACKAGING AND STORAGE: Package in sterile unit-dose 1-mL syringes. Store at 2°–8°.

BEYOND-USE DATE: In the absence of performing and completing a sterility test, the storage conditions in Pharmaceutical Compounding - Sterile

Preparations (797), 14.3 Establishing a BUD for a CSP apply.

LABELING: Label it to indicate that it is for veterinary use only. Label it to state that this is a single-dose container intended for use in the eye and to not use if a precipitate is present. Label it with a warning that it is not for injection. Label it to state the Beyond-Use Date.

USP REFERENCE STANDARDS (11)

USP Voriconazole RS