Acepromazine Maleate Injection

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 Injection is a sterile solution of Acepromazine Maleate in Water for Injection. It contains 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 volume of Injection, 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: Meets 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: 1 mg/mL of Acepromazine Maleate in 0.05 N hydrochloric acid from an appropriately diluted volume of Injection

Sample solution: Nominally 0.1 mg/mL of Acepromazine Maleate in water from Sample stock solution

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

3.3 System suitability

Sample: Standard solution

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 Injection 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 SPECIFIC TESTS

4.1 PH (791)

4.5-5.8

4.2 BACTERIAL ENDOTOXINS TEST (85)

NMT 4.5 USP Endotoxin Units/mg of acepromazine maleate

4.3 STERILITY TESTS (71)

It meets the requirements when tested as directed for Test for Sterility of the Product to Be Examined, Membrane Filtration.

4.4 OTHER REQUIREMENTS

It meets the requirements in Injections and Implanted Drug Products (1).

5 ADDITIONAL REQUIREMENTS

PACKAGING AND STORAGE: Preserve in tight, light-resistant, single-dose or multiple-dose containers as described in Packaging and Storage Requirements (659), Injection Packaging. Store at controlled room temperature.

LABELING: Label it to indicate that it is for veterinary use only.

USP REFERENCE STANDARDS (11)

USP Acepromazine Maleate RS