Mometasone Furoate Topical Solution

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

Mometasone Furoate Topical Solution is Mometasone Furoate in a suitable aqueous vehicle. It contains NLT 90.0% and NMT 110.0% of the labeled amount of mometasone furoate (C₂₇H₃₀Cl₂O₆).

2 IDENTIFICATION

Change to read:

2.1 A. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.

2.2 B. Thin-Layer Chromatographic Identification Test 〈201〉

Standard solution: 1 mg/mL of USP Mometasone Furoate RS in a mixture of chloroform and methanol (4:1)

Sample solution: Transfer the equivalent of 2 mg of mometasone furoate from Topical Solution to a 50-mL centrifuge tube. Add 10 mL of water. Extract the aqueous solution with 20 mL of chloroform. Remove the chloroform layer, dry over anhydrous sodium sulfate, and filter through a cotton pledget. Repeat the chloroform extraction, and combine the dried extracts. Evaporate the chloroform solution to dryness on a steam bath under a stream of nitrogen. Allow the sample specimen to cool to room temperature. Dissolve the residue in a mixture of chloroform and methanol (4:1) to obtain 1 mg/mL of Sample solution.

Application volume: 20 µL

Developing solvent system: Chloroform and ethyl acetate (3:1)

Acceptance criteria: The R_F value of the principal spot of the Sample solution corresponds to that of the Standard solution.

3 ASSAY

3.1 Procedure

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Diluent: Acetonitrile, water, and glacial acetic acid (50:50:1)

Solution A: Water

Solution B: Acetonitrile

Mobile phase: See Table 1.

Table 1

Standard solution: 0.1 mg/mL of USP Mometasone Furoate RS in Solution B

Sample solution: Transfer a portion of Topical Solution, equivalent to about 2.5 mg of mometasone furoate, to a 25-mL flask. Dilute with Diluent to volume, and mix. Pass a portion of the solution through a polypropylene filter of 0.2-µm pore size, discarding the first 1–2 mL of filtrate.

Chromatographic system

• (See Chromatography 〈621〉, System Suitability.)
• Mode: LC
• Detector: UV 254 nm
• Column: 4.6-mm × 25-cm; 5-µm packing L60
• Flow rate: 2 mL/min
• Injection size: 50 µL

System suitability

• Sample: Standard solution
• Suitability requirements:
• Tailing factor: NMT 1.5 for the mometasone furoate peak
• Relative standard deviation: NMT 2.0%

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of mometasone furoate (C₂₇H₃₀Cl₂O₆) in the portion of Topical Solution taken:

Result = (rᵤ/rₛ) × (Cₛ/Cᵤ) × 100

rᵤ = peak response from the Sample solution

rₛ = peak response from the Standard solution

Cₛ = concentration of USP Mometasone Furoate RS in the Standard solution (mg/mL)

Cᵤ = nominal concentration of mometasone furoate in the Sample solution (mg/mL)

Acceptance criteria: 90.0%–110.0%

4 IMPURITIES

4.1 Organic Impurities

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Diluent, Solution A, Solution B, Mobile phase, Standard solution, and Sample solution: Prepare as directed in the Assay.

System suitability solution: 0.1 µg/mL of USP Mometasone Furoate RS from Standard solution in Diluent

Chromatographic system

• (See Chromatography 〈621〉, System Suitability.)
• Mode: LC
• Detector: UV 254 nm
• Column: 4.6-mm × 25-cm; 5-µm packing L60
• Column temperature: 25 ± 5°
• Flow rate: 2 mL/min
• Injection size: 50 µL

System suitability

• Sample: System suitability solution
• Suitability requirements
• Relative standard deviation: NMT 10%

Analysis

Samples: Diluent, System suitability solution, and Sample solution

[Note-Exclude any peak areas less than that of the System suitability solution. Also, exclude any peaks with the same retention times as those observed in the Diluent. Any peaks having a relative retention time of 1.04 or 1.13 are controlled in the Mometasone Furoate monograph, and therefore are not included in the total specified and unspecified impurities limit.]

Calculate the percentage of each impurity in the portion of Topical Solution taken:

Result = (r_U/r_T) × 100

r_U = peak response of each impurity from the Sample solution

r_T = sum of all the peak responses from the Sample solution

Acceptance criteria: See Table 2.

Table 2

5 SPECIFIC TESTS

Microbial Enumeration Tests 〈61〉 and Tests for Specified Microorganisms 〈62〉: It meets the requirements of the tests for absence of Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, and Salmonella species.

pH 〈791〉: 4.0–5.0

6 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in well-closed containers, and store at controlled room temperature.

USP Reference Standards 〈11〉

USP Mometasone Furoate RS