Printed on: Tue Aug 03 2021, 07:30:13 AM Official Status: Currently Official on 03-Aug-2021 DocId: 1_GUID-37A2999C-BCC3-46AD-8C38-1C5992FD93F3_3_en-US

(EST)
Printed by: Le Tran Official Date: Official as of 01-May-2020 Document Type: USP @2021 USPC
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Suitability requirements
Voriconazole Compounded Ophthalmic Tailing factor: NMT 2.0
Solution, Veterinary Relative standard deviation: NMT 2.0% for replicate
injections
DEFINITION Analysis
Voriconazole Compounded Ophthalmic Solution, Veterinary Samples: Standard solution and Sample solution
contains NLT 90.0% and NMT 110.0% of the labeled Calculate the percentage of the labeled amount of
amount of voriconazole (C16H14F3N5O). voriconazole (C16H14F3N5O) in the portion of Ophthalmic
Prepare Voriconazole Compounded Ophthalmic Solution, Solution, Veterinary taken:
Veterinary 10 mg/mL as follows (see Pharmaceutical
Compounding—Sterile Preparations á797ñ). Result = (rU/rS) × (CS/CU) × 100

Voriconazole for Injectiona equivalent to 200 mg

rU = peak response of voriconazole from the Sample
solution
Sodium Chloride Injection (0.9%), a sufficient quan- rS = peak response of voriconazole from the Standard
tity to make 20 mL solution
a V-Fend 200-mg injection, Pfizer, Inc., Groton, CT. CS = concentration of voriconazole in the Standard
solution (mg/mL)
Reconstitute Voriconazole for Injection with Sodium Chloride CU = nominal concentration of voriconazole in the
Injection (0.9%) to bring to a final volume of 20 mL. Sample solution (mg/mL)
[NOTE—May reconstitute according to package insert to
Acceptance criteria: 90.0%–110.0%
achieve a 10-mg/mL solution.] Shake well until a clear

al
solution is achieved. Aseptically draw up into sterile unit-dose SPECIFIC TESTS
1-mL syringes. • PH á791ñ: 5.7–6.7
• STERILITY TESTS á71ñ: It meets the requirements when
ASSAY
tested as directed in Test for Sterility of the Product to be
• PROCEDURE
Examined, Membrane Filtration.
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.
ci • PARTICULATE MATTER IN OPHTHALMIC SOLUTIONS á789ñ: It
meets the requirements.
ADDITIONAL REQUIREMENTS
Standard solution: 0.25 mg/mL of voriconazole prepared • PACKAGING AND STORAGE: Package in sterile unit-dose
from USP Voriconazole RS in Mobile phase. Sonicate for 1-mL syringes. Store at 2°–8°.
ffi
about 5 min to dissolve.
Sample solution: Transfer 250 µL of Ophthalmic Solution, Change to read:
Veterinary into a 10-mL volumetric flask, dilute with
Mobile phase to volume, and mix well to dissolve. Protect • BEYOND-USE DATE: ▲NMT 60 days after the date on which
from light. it was compounded when stored in a refrigerator. In the
Chromatographic system absence of passing a sterility test, the storage period at cold
O

(See Chromatography á621ñ, System Suitability.) temperature for Low-Risk Level CSPs applies (see
Mode: LC Pharmaceutical Compounding—Sterile Preparations á797ñ,
Detector: UV 256 nm CSP Microbial Contamination Risk Levels).▲ (CN 1-May-2020)
Column: 3.9-mm × 15-cm; 5-µm packing L1 • LABELING: Label it to indicate that it is for veterinary use
Column temperature: 30° only. Label it to state that this is a single-dose container
Flow rate: 1.0 mL/min intended for use in the eye and to not use if a precipitate is
Injection volume: 10 µL present. Label it with a warning that it is not for injection.
System suitability Label it to state the Beyond-Use Date.
Sample: Standard solution • USP REFERENCE STANDARDS á11ñ
[NOTE—The retention time for voriconazole is about USP Voriconazole RS
4.2 min.]

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