USP-NF Acepromazine Maleate

11/27/2020 USP-NF Acepromazine Maleate
Printed on: Fri Nov 27 2020, 10:15:07 am

Printed by: Shruti Kharidia
O cial Status: Currently O cial on 27-Nov-2020
O cial Date: O cial as of 1-May-2020
Document Type: USP
DocId: 1_GUID-4931EEC7-CE84-4DA3-AB2E-0D16ED840FBF_4_en-US
Printed from: https://online.uspnf.com/uspnf/document/1_GUID-4931EEC7-CE84-4DA3-AB2E-0D16ED840FBF_4_en-US
© 2020 USPC
Acepromazine Maleate
C19H22N2OS · C4H4O4 442.53
Ethanone, 1-[10-[3-(dimethylamino)propyl]-10H-phenothiazin-2-yl]-, (Z)-2-butenedioate (1:1);
10-[3-(Dimethylamino)propyl]phenothiazin-2-yl methyl ketone maleate (1:1) [3598-37-6]; UNII: 37862HP2OM.
DEFINITION
Acepromazine Maleate contains NLT 98.0% and NMT 101.0% of acepromazine maleate (C19H22N2OS · C4H4O4), calculated on the
anhydrous basis.
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.
IDENTIFICATION
Change to read:
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• A. ▲SPECTROSCOPIC IDENTIFICATION TESTS 〈197〉, Infrared Spectroscopy: 197K▲ (CN 1-MAY-2020)
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• B. The retention time of the major peak for acepromazine of the Sample solution corresponds to that of the Standard solution, as
obtained in the Assay.
ASSAY
• PROCEDURE
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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
FF
Sample solution: 0.1 mg/mL of Acepromazine Maleate in water from Sample stock solution
Chromatographic system
(See Chromatography 〈621〉, System Suitability.)
Mode: LC
Detector: UV 280 nm
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Column: 4-mm × 15-cm; 5-µm packing L7

Flow rate: 1 mL/min
Injection volume: 10 µL
System suitability
Sample: Standard solution
Suitability requirements
Column e ciency: NLT 1500 theoretical plates
Tailing factor: NMT 2.5
Relative standard deviation: NMT 2.0%
Analysis
Samples: Standard solution and Sample solution
Calculate the percentage of acepromazine maleate (C19H22N2OS · C4H4O4) in the portion of Acepromazine Maleate taken:
Result = (rU/rS) × (CS/CU) × 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)
https://online.uspnf.com/uspnf/document/1_GUID-4931EEC7-CE84-4DA3-AB2E-0D16ED840FBF_4_en-US?source=TOC 1/2
11/27/2020 USP-NF Acepromazine Maleate
CU = concentration of the Sample solution (mg/mL)
Acceptance criteria: 98.0%–101.0% on the anhydrous basis
IMPURITIES
• RESIDUE ON IGNITION 〈281〉: NMT 0.2%
• ORGANIC IMPURITIES
Conduct this test without exposure to daylight, and with the minimum necessary exposure to arti cial light.
Diluent: Methanol and diethylamine (19:1)
Sample solution: 20.0 mg/mL of Acepromazine Maleate in Diluent
Standard solution: 0.1 mg/mL of Acepromazine Maleate in Diluent from the Sample solution
Chromatographic system
(See Chromatography 〈621〉, Thin-Layer Chromatography.)
Mode: TLC
Adsorbent: 0.25-mm layer of chromatographic silica gel mixture
Application volume: 10 µL
Developing solvent system: n-Heptane, isobutyl alcohol, and diethylamine (75:17:8)
Analysis
Samples: Standard solution and Sample solution
Develop the chromatogram in the Developing solvent system until the solvent front has moved three-fourths the length of the
plate. Remove the plate from the chamber and allow to air dry. Examine the plate under short-wavelength UV light.
Acceptance criteria: 0.5%; no spot, other than the principal acepromazine spot and any at the origin, observed in the chromatogram of
the Sample solution is more intense than the principal spot observed in the chromatogram of the Standard solution.
SPECIFIC TESTS
• MELTING RANGE OR TEMPERATURE 〈741〉: 136°–139°
• PH 〈791〉
Sample solution: 10 mg/mL of Acepromazine Maleate in water
Acceptance criteria: 4.0–5.5
• WATER DETERMINATION, Method I〈921〉: NMT 1.0%
L
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ADDITIONAL REQUIREMENTS
• PACKAGING AND STORAGE: Preserve in well-closed containers, protected from light. Store at room temperature.
• LABELING: Label it to indicate that it is for veterinary use only.
• USP REFERENCE STANDARDS 〈11〉
IC
USP Acepromazine Maleate RS
Auxiliary Information- Please check for your question in the FAQs before contacting USP.
FF
Topic/Question Contact Expert Committee
ACEPROMAZINE MALEATE Morgan Puderbaugh SM32020 Small Molecules 3

Senior Scienti c Liaison
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Chromatographic Database Information: Chromatographic Database
Most Recently Appeared In:

Pharmacopeial Forum: Volume No. 29(6)
Page Information:
USP43-NF38 - 36
USP42-NF37 - 38
USP41-NF36 - 32
Current DocID: GUID-4931EEC7-CE84-4DA3-AB2E-0D16ED840FBF_4_en-US
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11/27/2020 USP-NF Acepromazine Maleate

Printed on: Fri Nov 27 2020, 10:15:07 am

Column: 4-mm × 15-cm; 5-µm packing L7

Result = (rU/rS) × (CS/CU) × 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 basis

USP Acepromazine Maleate RS

Topic/Question Contact Expert Committee

ACEPROMAZINE MALEATE Morgan Puderbaugh SM32020 Small Molecules 3

Chromatographic Database Information: Chromatographic Database

Most Recently Appeared In:

Current DocID: GUID-4931EEC7-CE84-4DA3-AB2E-0D16ED840FBF_4_en-US

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