Printed on: Fri Jan 05 2024, 09:47:14 PM(EST) Status: Currently Official on 06-Jan-2024 DocId: GUID-1E2F0F61-3527-4BB7-8FE8-B977280F2430_4_en-US

Printed by: USP NF Official Date: Official as of 01-May-2020 Document Type: USP @2024 USPC
Do Not Distribute DOI Ref: sw644 DOI: https://doi.org/10.31003/USPNF_M137_04_01
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Detector: UV 280 nm
Acepromazine Maleate Injection Column: 4-mm × 15-cm; 5-µm packing L7
DEFINITION Flow rate: 1 mL/min
Acepromazine Maleate Injection is a sterile solution of Injection volume: 10 µL
Acepromazine Maleate in Water for Injection. It contains NLT System suitability
90.0% and NMT 110.0% of the labeled amount of Sample: Standard solution
acepromazine maleate (C19H22N2OS · C4H4O4). Suitability requirements
Column efficiency: NLT 1500 theoretical plates
Throughout the following procedures, protect samples, the
Tailing factor: NMT 2.5
USP Reference Standard, and solutions containing them, by
Relative standard deviation: NMT 2.0%
conducting the procedures without delay, under subdued
Analysis
light, or using low-actinic glassware.
Samples: Standard solution and Sample solution
IDENTIFICATION Calculate the percentage of acepromazine maleate
(C19H22N2OS · C4H4O4) in the portion of Injection taken:
Change to read:
Result = (r U/r S) × (C S/C U) × 100
• A. ▲SPECTROSCOPIC IDENTIFICATION TESTS á197ñ, Infrared
Spectroscopy: 197K▲ (CN 1-May-2020) rU = peak area from the Sample solution
Sample: To a volume of Injection, equivalent to 20 mg of rS = peak area from the Standard solution
acepromazine maleate, add 2 mL of water and 3 mL of 2 N
sodium hydroxide, and extract with two 5-mL portions of CS = concentration of USP Acepromazine Maleate RS
cyclohexane. Combine the cyclohexane extracts, and in the Standard solution (mg/mL)
evaporate to dryness under vacuum, using gentle heat if CU = nominal concentration of the Sample solution

al
necessary. (mg/mL)
Acceptance criteria: Meets the requirements
Acceptance criteria: 90.0%–110.0%
• B. The retention time of the major peak of the Sample
solution corresponds to that of the Standard solution, as SPECIFIC TESTS
obtained in the Assay. ci • PH á791ñ: 4.5–5.8
• BACTERIAL ENDOTOXINS TEST á85ñ: NMT 4.5 USP Endotoxin
ASSAY
Units/mg of acepromazine maleate
• PROCEDURE
• STERILITY TESTS á71ñ: It meets the requirements when
Buffer: Add 6 mL of triethylamine to 700 mL of water, and
tested as directed for Test for Sterility of the Product to Be
adjust with phosphoric acid to a pH of 2.5.
Examined, Membrane Filtration.
Mobile phase: Acetonitrile and Buffer (300:700)
ffi
• OTHER REQUIREMENTS: It meets the requirements in
Standard stock solution: 1 mg/mL of USP Acepromazine
Injections and Implanted Drug Products á1ñ.
Maleate RS in 0.05 N hydrochloric acid
Standard solution: 0.1 mg/mL of USP Acepromazine ADDITIONAL REQUIREMENTS
Maleate RS in water from Standard stock solution • PACKAGING AND STORAGE: Preserve in tight, light-resistant,
Sample stock solution: 1 mg/mL of Acepromazine Maleate single-dose or multiple-dose containers as described in
in 0.05 N hydrochloric acid from an appropriately diluted Packaging and Storage Requirements á659ñ, Injection
O

volume of Injection Packaging. Store at controlled room temperature.

Sample solution: Nominally 0.1 mg/mL of Acepromazine • LABELING: Label it to indicate that it is for veterinary
Maleate in water from Sample stock solution use only.
Chromatographic system • USP REFERENCE STANDARDS á11ñ
(See Chromatography á621ñ, System Suitability.) USP Acepromazine Maleate RS
Mode: LC

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