Acepromazine Maleate Tablets

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

Acepromazine Maleate Tablets contain NLT 90.0% and NMT 110.0% of the labeled amount of acepromazine maleate (C₁₉H₂₂N₂OS·C₄H₄O₄).

Throughout the following procedures, protect samples, the USP Reference Standard, and solutions containing them, by conducting the procedures without delay, under subdued light, or using low-actinic glassware.

2 IDENTIFICATION

Change to read:

A. SPECTROSCOPIC IDENTIFICATION TESTS (197), Infrared Spectroscopy: 197K (CN 1-MAY-2020)

Sample: To a quantity of powdered Tablets, equivalent to 20 mg of acepromazine maleate, add 2 mL of water and 3 mL of 2 N sodium hydroxide, and extract with two 5-mL portions of cyclohexane. Combine the cyclohexane extracts, and evaporate to dryness under vacuum, using gentle heat if necessary.

Acceptance criteria: Meet 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

Buffer: Add 6 mL of triethylamine to 700 mL of water, and adjust with phosphoric acid to a pH of 2.5.

Mobile phase: Acetonitrile and Buffer (300:700)

Standard stock solution: 1 mg/mL of USP Acepromazine Maleate RS in 0.05 N hydrochloric acid

Standard solution: 0.1 mg/mL of USP Acepromazine Maleate RS in water from Standard stock solution

Sample stock solution: Transfer NLT 10 Tablets to a 200-mL volumetric flask, add 100 mL of 0.05 N hydrochloric acid, and sonicate for 10 min. Shake by mechanical means for 30 min, and dilute with 0.05 N hydrochloric acid to volume.

Sample solution: Nominally 0.1 mg/mL of Acepromazine Maleate in water from Sample stock solution. Pass a portion of this solution through a filter of 0.5-µm or finer pore size.

3.2 Chromatographic system

(See Chromatography (621), System Suitability.)

Mode: LC

Detector: UV 280 nm

Column: 4-mm x 15-cm; 5-µm packing L7

Flow rate: 1 mL/min

Injection volume: 10 µL

System suitability

Sample: Standard solution

3.3 Suitability requirements

Column efficiency: NLT 1500 theoretical plates

Tailing factor: NMT 2.5

Relative standard deviation: NMT 2.0%

3.4 Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of acepromazine maleate (C₁₉H₂₂N₂OS·C₄H₄O₄) in the portion of Tablets taken:

Result = (r_U/r_S) x (C_S/C_U) × 100

r_U = peak area from the Sample solution

r_S = peak area from the Standard solution

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

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

Acceptance criteria: 90.0%-110.0%

4 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in tight, light-resistant containers, and store at controlled room temperature.

Labeling: Label the Tablets to indicate that they are for veterinary use only.

USP REFERENCE STANDARDS (11)

USP Acepromazine Maleate RS