Beclomethasone Dipropionate Compounded Oral 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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DEFINITION

Beclomethasone Dipropionate Compounded Oral Solution contains NLT 90.0% and NMT 110.0% of the labeled amount of beclomethasone dipropionate (C₂₈H₃₇ClO₇).

Prepare Beclomethasone Dipropionate Compounded Oral Solution 0.5 mg/mL as follows (see Pharmaceutical Compounding—Nonsterile Preparations 〈795〉).

Pour the Beclomethasone Dipropionate powder into a suitable container. Wet the powder with a small amount of Corn Oil and triturate to make a smooth paste. Add the Corn Oil to make the contents pourable. Transfer contents stepwise and quantitatively to a calibrated container using the Corn Oil. Add sufficient Corn Oil to bring to final volume. Place on a shaker until dissolved. [Note—May take up to 24 h to dissolve.]

1 ASSAY

Procedure

Mobile phase: Acetonitrile and water (65:35)

Standard stock solution: 0.5 mg/mL of beclomethasone dipropionate prepared from USP Beclomethasone Dipropionate RS in ethanol. Sonicate and mix well.

Standard solution: 0.02 mg/mL of beclomethasone dipropionate prepared from Standard stock solution and ethanol

Sample solution: Transfer 1.0 mL of Oral Solution to a 25-mL volumetric flask, add approximately 20 mL of ethanol, vortex for 30 s, and warm under running water until dissolved. Dilute with Ethanol to volume.

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV-Vis 240 nm

Column: 2.0-mm × 10-cm; 2.5-µm packing L1

Column temperature: 35°

Flow rate: 0.35 mL/min

Injection volume: 5 µL

System suitability

Sample: Standard solution

[Note—The retention time for beclomethasone dipropionate is about 3.2 min.]

Suitability requirements

Tailing factor: NMT 2.0

Relative standard deviation: NMT 2.0% for replicate injections

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of beclomethasone dipropionate (C₂₈H₃₇ClO₇) in the portion of Oral Solution taken:

Result = (rᵤ/rₛ) × (Cₛ/Cᵤ) × 100

rᵤ = peak response of beclomethasone dipropionate from the Sample solution

rₛ = peak response of beclomethasone dipropionate from the Standard solution

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

Cᵤ = nominal concentration of beclomethasone dipropionate in the Sample solution (mg/mL)

Acceptance criteria: 90.0%–110.0%

2 ADDITIONAL REQUIREMENTS

Packaging and Storage: Package in tight, light-resistant, plastic containers. Store at controlled room temperature.

Beyond-Use Date: NMT 90 days after the date on which it was compounded when stored at controlled room temperature.

Labeling: Label it to be well-shaken before use, and to state the Beyond-Use Date.

USP Reference Standards 〈11〉

USP Beclomethasone Dipropionate RS