Benazepril Hydrochloride Compounded Oral Suspension, 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

Benazepril Hydrochloride Compounded Oral Suspension, Veterinary contains NLT 90.0% and NMT 110.0% of the labeled amount of benazepril hydrochloride (C₂₄H₂₈N₂O₅.HCI).

Prepare Benazepril Hydrochloride Compounded Oral Suspension, Veterinary, 5 mg/mL, as follows (see Pharmaceutical Compounding-Nonsterile Preparations (795)).

^a Perrigo Pharmaceuticals, Allegan, MI.

Pour the Benazepril Hydrochloride powder into a suitable container. Wet the powder with a small amount of Vehicle, and triturate to make a smooth paste. Add the Vehicle to make the contents pourable. Transfer the contents, stepwise and quantitatively, to a calibrated container using the remainder of the Vehicle. Add sufficient Vehicle to bring to final volume. Shake to mix well.

2 ASSAY

2.1 PROCEDURE

Solution A: 25 mM sodium phosphate adjusted with phosphoric acid to a pH of 3.0. Pass through a nylon filter of 0.45-µm pore size.

Mobile phase: Acetonitrile and Solution A (40:60)

Diluent: Water adjusted with phosphoric acid to a pH of 3.0

Standard stock solution: 5 mg/mL of USP Benazepril Hydrochloride RS in Diluent. Sonicate for 3 min. Mix well, and store at 2°-8°.

Standard solution: 0.01 mg/mL of benazepril hydrochloride prepared with Standard stock solution and Diluent. Centrifuge for 5 min at 14,000 rpm, and use the supernatant. Protect from light, and store at 2°-8°.

Sample solution: Shake thoroughly each bottle of Oral Suspension, Veterinary. Transfer 2.0 mL of the Oral Suspension, Veterinary into a 1-L volumetric flask, and dilute with Diluent to volume. Mix well. Centrifuge for 5 min at 14,000 rpm, and use the supernatant. Protect from light, and store at 2°-8°

Chromatographic system

(See Chromatography (621), System Suitability.)

Mode: LC

Detector: UV 210 nm

Column: 4.6-mm × 25-cm; 5-µm packing L1

Temperatures

Column: 30°

Autosampler: 5°

Flow rate: 1.2 mL/min

Injection volume: 25 µL

System suitability

Sample: Standard solution

[NOTE-The retention time for benazepril hydrochloride is about 6.5 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 benazepril hydrochloride (C₂₄H₂₈N₂O₅.HCI) in the portion of Oral Suspension,

Veterinary taken:

Result = (r_U/r_S) × (C_S/C_U) × 100

r_U = peak response of benazepril hydrochloride from the Sample solution

r_S = peak response of benazepril hydrochloride from the Standard solution

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

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

Acceptance criteria: 90.0%-110.0%

3 SPECIFIC TESTS

PH (791): 3.8-4.8

4 ADDITIONAL REQUIREMENTS

PACKAGING AND STORAGE: Package in tight, light-resistant containers. Store at 2°-8° or at controlled room temperature.

LABELING: Label it to indicate that it is to be well-shaken before use, and to state the Beyond-Use Date. Label it to state that it is for veterinary use only.

BEYOND-USE DATE: NMT 90 days after the date on which it was compounded when stored at 2°-8° or at controlled room temperature

USP REFERENCE STANDARDS (11).

USP Benazepril Hydrochloride RS