Printed on: Sat Jun 26 2021, 05:47:46 AM Official Status: Currently Official on 26-Jun-2021 DocId: 1_GUID-4931EEC7-CE84-4DA3-AB2E-0D16ED840FBF_4_en-US

(EST)
Printed by: Nguyen Nhan Official Date: Official as of 01-May-2020 Document Type: USP @2021 USPC
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Relative standard deviation: NMT 2.0%

Acepromazine Maleate Analysis
Samples: Standard solution and Sample solution
Calculate the percentage of acepromazine maleate
(C19H22N2OS · C4H4O4) in the portion of Acepromazine
Maleate taken:

Result = (r U/r S) × (C S/C U) × 100

rU = peak area response from the Sample solution

rS = peak area response from the Standard solution
CS = concentration of USP Acepromazine Maleate RS
in the Standard solution (mg/mL)
CU = concentration of the Sample solution (mg/mL)

Acceptance criteria: 98.0%–101.0% on the anhydrous

C19H22N2OS · C4H4O4 442.53 basis
Ethanone, 1-[10-[3-(dimethylamino)propyl]-
10H-phenothiazin-2-yl]-, (Z)-2-butenedioate (1:1); IMPURITIES
10-[3-(Dimethylamino)propyl]phenothiazin-2-yl methyl • RESIDUE ON IGNITION á281ñ: NMT 0.2%
ketone maleate (1:1) [3598-37-6]. • ORGANIC IMPURITIES
Conduct this test without exposure to daylight, and with the
DEFINITION minimum necessary exposure to artificial light.

al
Acepromazine Maleate contains NLT 98.0% and NMT 101.0% Diluent: Methanol and diethylamine (19:1)
of acepromazine maleate (C19H22N2OS · C4H4O4), calculated Sample solution: 20.0 mg/mL of Acepromazine Maleate in
on the anhydrous basis. Diluent
Throughout the following procedures, protect samples, the Standard solution: 0.1 mg/mL of Acepromazine Maleate in
USP Reference Standard, and solutions containing them, by Diluent from the Sample solution
conducting the procedures without delay, under subdued
light, or using low-actinic glassware.
IDENTIFICATION
ci Chromatographic system
(See Chromatography á621ñ, Thin-Layer Chromatography.)
Mode: TLC
Adsorbent: 0.25-mm layer of chromatographic silica gel
Change to read: mixture
ffi
Application volume: 10 µL
• A. ▲SPECTROSCOPIC IDENTIFICATION TESTS á197ñ, Infrared Developing solvent system: n-Heptane, isobutyl alcohol,
Spectroscopy: 197K▲ (CN 1-May-2020) and diethylamine (75:17:8)
• B. The retention time of the major peak for acepromazine Analysis
of the Sample solution corresponds to that of the Standard Samples: Standard solution and Sample solution
solution, as obtained in the Assay. Develop the chromatogram in the Developing solvent
O

system until the solvent front has moved three-fourths

ASSAY the length of the plate. Remove the plate from the
• PROCEDURE chamber and allow to air dry. Examine the plate under
Buffer: Add 6 mL of triethylamine to 700 mL of water, and short-wavelength UV light.
adjust with phosphoric acid to a pH of 2.5. Acceptance criteria: 0.5%; no spot, other than the principal
Mobile phase: Acetonitrile and Buffer (300:700) acepromazine spot and any at the origin, observed in the
Standard stock solution: 1 mg/mL of USP Acepromazine chromatogram of the Sample solution is more intense than
Maleate RS in 0.05 N hydrochloric acid the principal spot observed in the chromatogram of the
Standard solution: 0.1 mg/mL of USP Acepromazine Standard solution.
Maleate RS in water from Standard stock solution
Sample stock solution: 1 mg/mL of Acepromazine Maleate SPECIFIC TESTS
in 0.05 N hydrochloric acid • MELTING RANGE OR TEMPERATURE á741ñ: 136°–139°
Sample solution: 0.1 mg/mL of Acepromazine Maleate in • PH á791ñ
water from Sample stock solution Sample solution: 10 mg/mL of Acepromazine Maleate in
Chromatographic system water
(See Chromatography á621ñ, System Suitability.) Acceptance criteria: 4.0–5.5
Mode: LC • WATER DETERMINATION, Method I á921ñ: NMT 1.0%
Detector: UV 280 nm
Column: 4-mm × 15-cm; 5-µm packing L7 ADDITIONAL REQUIREMENTS
Flow rate: 1 mL/min • PACKAGING AND STORAGE: Preserve in well-closed
Injection volume: 10 µL containers, protected from light. Store at room
System suitability temperature.
Sample: Standard solution • LABELING: Label it to indicate that it is for veterinary
Suitability requirements use only.
Column efficiency: NLT 1500 theoretical plates • USP REFERENCE STANDARDS á11ñ
Tailing factor: NMT 2.5 USP Acepromazine Maleate RS

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