Beclomethasone Dipropionate

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

DOWNLOAD PDF HERE

1 DEFINITION

Beclomethasone Dipropionate is anhydrous or contains one molecule of water of hydration. It contains NLT 97.0% and NMT 103.0% of beclomethasone dipropionate (C₂₈H₃₇ClO₇), calculated on the dried basis.

2 IDENTIFICATION

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

3 ASSAY

Procedure

Mobile phase: Acetonitrile and water (60:40) such that the retention times for beclomethasone dipropionate and Testosterone propionate are approximately 6 and 10 min, respectively

Internal standard solution: 1.2 mg/mL of USP Testosterone Propionate RS in methanol

Standard stock solution: 1.4 mg/mL of USP Beclomethasone Dipropionate RS in methanol

Standard solution: 0.7 mg/mL of USP Beclomethasone Dipropionate RS and 0.6 mg/mL of USP Testosterone Propionate RS prepared as follows. Transfer 4.0 mL of Standard stock solution to a suitable vial, and add 4.0 mL of Internal standard solution.

Sample stock solution: 1.4 mg/mL of Beclomethasone Dipropionate in methanol

Sample solution: 0.7 mg/mL of Beclomethasone Dipropionate and 0.6 mg/mL of USP Testosterone Propionate RS prepared as follows. Transfer 4.0 mL of Sample stock solution to a suitable vial, and add 4.0 mL of Internal standard solution.

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 254 nm

Column: 4-mm × 30-cm; packing L1

Injection volume: 5–25 µL

System suitability

Sample: Standard solution

Suitability requirements

Relative standard deviation: NMT 3.0% for five replicate injections

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of beclomethasone dipropionate (C₂₈H₃₇ClO₇) in the portion of Beclomethasone Dipropionate taken:

Result = (Rᵤ/Rₛ) × (Cₛ/Cᵤ) × 100

Rᵤ = peak height ratio of beclomethasone dipropionate to the internal standard from the Sample solution

Rₛ = peak height ratio of beclomethasone dipropionate to the internal standard from the Standard solution

Cₛ = concentration of USP Beclomethasone Dipropionate RS in the Standard solution (mg/mL)

Cᵤ = concentration of Beclomethasone Dipropionate in the Sample solution (mg/mL)

Acceptance criteria: 97.0%–103.0% on the dried basis

4 IMPURITIES

Residue on Ignition 〈281〉: NMT 0.1%

5 SPECIFIC TESTS

Optical Rotation, Specific Rotation 〈781S〉

Sample solution: 10 mg/mL in dioxane

Acceptance criteria: +88° to +94°

Loss on Drying 〈731〉

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

Acceptance criteria: NMT 0.5% for the anhydrous form; 2.8%–3.8% for the monohydrate form

6 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in well-closed containers.

USP Reference Standards 〈11〉

USP Beclomethasone Dipropionate RS

USP Testosterone Propionate RS