Butoconazole Nitrate

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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C₁₉H₁₇Cl₃N₂S . HNO₃  474.79

1H-Imidazole, 1-[4-(4-chlorophenyl)-2-[(2,6-dichlorophenyl)thio] butyl-, mononitrate, (±)-;

(+)-1-[4-(p-Chlorophenyl)-2-[(2,6-dichlorophenyl) thio] butyl]imidazole mononitrate CAS RN^®: 64872-77-1; UNII: 4805237NP5.

1 DEFINITION

Butoconazole Nitrate contains NLT 98.0% and NMT 102.0% of butoconazole nitrate (C₁₉H₁₇Cl₃N₂S . HNO₃), calculated on the dried basis.

2 IDENTIFICATION

Change to read:

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

3 ASSAY

3.1 PROCEDURE

Buffer: 2.18 g/L of monobasic potassium phosphate and 4.18 g/L of dibasic potassium phosphate in water

Mobile phase: Methanol and Buffer (3:1)

Standard solution: 0.2 mg/mL of USP Butoconazole Nitrate RS in Mobile phase

Sample solution: 0.2 mg/mL of Butoconazole Nitrate in Mobile phase. Filter.

Chromatographic system

(See Chromatography (621), System Suitability.)

Mode: LC

Detector: UV 229 nm

Column: 4.6-mm x 25-cm; packing L1

Column temperature: 40°

Flow rate: 2 mL/min

Injection volume: 10 µL

System suitability

Sample: Standard solution

Suitability requirements

Column efficiency: NLT 2800 theoretical plates

Tailing factor: NMT 1.5

Relative standard deviation: NMT 1.5%

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage age of butoconazole nitrate (C₁₉H₁₇Cl₃N₂S . HNO₃) in the portion of Butoconazole Nitrate taken:

Result = (r_U/r_S) × (C_S/C_U) × 100

r_U = peak response from the Sample solution

r_S = peak response from the Standard solution

C_S = concentration of USP Butoconazole Nitrate RS in the Standard solution (mg/mL)

C_U = concentration of Butoconazole Nitrate in the Sample solution (mg/mL)

Acceptance criteria: 98.0%-102.0% on the dried basis

4 IMPURITIES

RESIDUE ON IGNITION (281): NMT 0.1%

ORDINARY IMPURITIES (466)

Standard solutions: USP Butoconazole Nitrate RS in a mixture of methylene chloride and methanol (2:1)

Test solution: Butoconazole Nitrate in a mixture of methylene chloride and methanol (2:1)

Eluant: Chloroform, tetrahydrofuran, cyclohexane, and ammonium hydroxide (18:18:13:1)

Visualization: 22

Acceptance criteria: Meets the requirements

5 SPECIFIC TESTS

LOSS ON DRYING (731)

Analysis: Dry under vacuum at 60° for 3 h.

Acceptance criteria: NMT 1.0%

6 ADDITIONAL REQUIREMENTS

PACKAGING AND STORAGE: Preserve in well-closed, light-resistant containers.

USP REFERENCE STANDARDS (11)

USP Butoconazole Nitrate RS