Cyclosporine 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)

DOWNLOAD PDF HERE

1 DEFINITION

Cyclosporine Compounded Ophthalmic Solution, Veterinary contains NLT 90.0% and NMT 110.0% of the labeled amount of cyclosporine (C₆₂H₁₁₁N₁₁O₁₂).

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

^a Sandimmune Oral Solution 100 mg/mL, Novartis Pharmaceuticals Corporation, East Hanover, NJ.

Mix the Cyclosporine Oral Solution with sufficient Corn Oil to bring to final volume and mix thoroughly. Pass the solution through a compatible sterile membrane filter of 0.22-µm pore size into a sterile ophthalmic container. Replace the tip and cap, and mix well. [NOTE-Cyclosporine Oral Solution Modified is not interchangeable and should not be used.]

2 ASSAY

2.1 PROCEDURE

Mobile phase: See Table 1.

Table 1

Standard solution: 0.5 mg/mL of cyclosporine prepared from USP Cyclosporine RS in acetonitrile. Mix well to dissolve.

Sample solution: Transfer 0.5 mL of Ophthalmic Solution, Veterinary into a 10-mL volumetric flask, dilute with acetonitrile to volume, and mix well. Allow the oil to separate from the solution. Once the top layer appears clear, transfer about 1 mL of the top layer into an amber HPLC vial.

2.1.1 Chromatographic system

(See Chromatography (621), System Suitability..)

Mode: LC

Detector: UV-Vis 208 nm

Column: 4.6-mm × 10-cm; 2.6-µm packing L1

Column temperature: 60°

Flow rate: 0.5 mL/min

Injection volume: 10 µL

2.1.2 System suitability

Sample: Standard solution

[NOTE-The retention time for cyclosporine is about 34.0 min.]

2.1.3 Suitability requirements

Tailing factor: NMT 2.0

Relative standard deviation: NMT 2.0% for replicate injections

2.1.4 Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of cyclosporine (C₆₂H₁₁₁N₁₁O₁₂) in the portion of Ophthalmic Solution, Veterinary taken:

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

r_U = peak response of cyclosporine from the Sample solution

r_S = peak response of cyclosporine from the Standard solution

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

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

Acceptance criteria: 90.0%-110.0%

3 SPECIFIC TESTS

STERILITY TESTS (71); It meets the requirements.

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 ophthalmic dropper bottles, protected from light. Store at controlled room temperature.

BEYOND-USE DATE: In the absence of performing and completing a sterility test, the storage conditions for High-Risk Level

CSPs in Pharmaceutical Compounding-Sterile Preparations (797) apply. After successful completion of sterility testing, NMT 180 days after the date on which it was compounded when stored at controlled room temperature.

LABELING: Label it to indicate that it is for veterinary use only. State that it is intended for use in the eye and to not use if a precipitate is present. State the Beyond-Use Date.

USP REFERENCE STANDARDS (11)

USP Cyclosporine RS