Mometasone Furoate

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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C₂₇H₃₀Cl₂O₆ 521.43

Pregna-1,4-diene-3,20-dione, 9,21-dichloro-17-[(2-furanylcarbonyl)oxy]-11-hydroxy-16-methyl-, (11β,16α)-;

9,21-Dichloro-11β,17-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione 17-(2-furoate)  CAS RN®: 83919-23-7; UNII: 04201GDN4R.

1 DEFINITION

Mometasone Furoate contains NLT 97.0% and NMT 102.0% of mometasone furoate (C₂₇H₃₀Cl₂O₆), calculated on the dried basis.

2 IDENTIFICATION

Change to read:

A. Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197M

B. The retention time of the Sample solution corresponds to that of the Standard solution, both relative to the internal standard, as obtained in the Assay.

3 ASSAY

3.1 Procedure

Mobile phase: Methanol and water (65:35)

Diluent: Methanol, acetic acid, and water (65:0.2:35)

Internal standard solution: 0.4 mg/mL of beclomethasone dipropionate in Diluent

Standard stock solution: 0.1 mg/mL of USP Mometasone Furoate RS, prepared by dissolving USP Mometasone Furoate RS in methanol and diluting quantitatively and stepwise, if necessary, with Diluent

Standard solution: 0.02 mg/mL of USP Mometasone Furoate RS and 0.08 mg/mL of beclomethasone dipropionate, prepared by pipetting equal volumes of Standard stock solution and Internal standard solution into a suitable volumetric flask and diluting with Diluent to volume, if necessary

Sample stock solution: 0.1 mg/mL of mometasone furoate, prepared by dissolving Mometasone Furoate in methanol and diluting quantitatively and stepwise, if necessary, with Diluent

Sample solution: 0.02 mg/mL of mometasone furoate and 0.08 mg/mL of beclomethasone dipropionate, prepared by pipetting 10 mL each of Sample stock solution and Internal standard solution into a 50-mL volumetric flask and diluting with Diluent to volume

Chromatographic system

• (See Chromatography 〈621〉, System Suitability.)
• Mode: LC
• Detector: UV 254 nm
• Column: 4.6-mm × 25-cm; packing L7
• Flow rate: 1.7 mL/min
• Injection size: 20 µL

System suitability

• Sample: Standard solution
• [Note-The relative retention times for mometasone furoate and beclomethasone dipropionate are about 1.0 and 1.6, respectively.]
• Suitability requirements
• Resolution: NLT 4.0 between the mometasone furoate and beclomethasone dipropionate peaks
• Tailing factor: NMT 1.8 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 Mometasone Furoate taken:

Result = (Rᵤ/Rₛ) × (Cₛ/Cᵤ) × 100

Rᵤ = peak response ratio of mometasone furoate to the internal standard from the Sample solution

Rₛ = peak response ratio of mometasone furoate to the internal standard from the Standard solution

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

Cᵤ = concentration of Mometasone Furoate in the Sample solution (mg/mL)

Acceptance criteria: 97.0%–102.0% on the dried basis

4 IMPURITIES

4.1 Residue on Ignition 〈281〉: NMT 0.1%

4.2 Organic Impurities

Standard stock solution: 10 mg/mL of USP Mometasone Furoate RS in dichloromethane

Standard solution A (5%): 0.5 mg/mL of USP Mometasone Furoate RS in dichloromethane, from the Standard stock solution

Standard solution B (2%): 0.2 mg/mL of USP Mometasone Furoate RS in dichloromethane, from the Standard stock solution

Standard solution C (1%): 0.1 mg/mL of USP Mometasone Furoate RS in dichloromethane, from the Standard stock solution

Standard solution D (0.2%): 0.02 mg/mL of USP Mometasone Furoate RS in dichloromethane, from the Standard stock solution

Standard solution E (0.1%): 0.01 mg/mL of USP Mometasone Furoate RS in dichloromethane, from the Standard stock solution

Sample solution: 10 mg/mL of Mometasone Furoate in dichloromethane

Chromatographic system

• (See Chromatography 〈621〉, Thin-Layer Chromatography.)
• Mode: TLC
• Adsorbent: 0.25-mm layer of chromatographic silica gel
• Application volume: 40 µL
• Developing solvent system: Chloroform and ethyl acetate (3:1)

Analysis

Samples: Standard solutions and Sample solution

Proceed as directed in the chapter. Examine the plate under short-wavelength UV light. Compare the intensities of any secondary spots from the Sample solution with those of the principal spots from the Standard solutions.

Acceptance criteria: No secondary spot from the Sample solution is larger or more intense than the principal spot from Standard solution C; and the sum of the intensities of the secondary spots from the Sample solution is NMT 2.0%.

5 SPECIFIC TESTS

5.1 Optical Rotation, Specific Rotation 〈781S〉

Sample solution: 5 mg/mL in dioxane

Acceptance criteria: +56° to +62°

5.2 Loss on Drying 〈731〉

Analysis: Dry a sample at 105° for 3 h.

Acceptance criteria: NMT 0.5%

6 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in well-closed containers.

USP Reference Standards 〈11〉

USP Mometasone Furoate RS