Sotalol Hydrochloride Compounded Oral Suspension

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

Sotalol Hydrochloride Compounded Oral Suspension contains NLT 90.0% and NMT 110.0% of the labeled amount of sotalol hydrochloride (C₁₂H₂₀N₂O₃S · HCl).

Prepare Sotalol Hydrochloride Compounded Oral Suspension 5 mg/mL as follows (see Pharmaceutical Compounding—Nonsterile Preparations 〈 795〉).

^a Betapace 120-mg tablets, Berlex Laboratories, Wayne, NJ.

^b Paddock Laboratories, Minneapolis, MN.

Calculate the required quantity of each ingredient for the total amount to be prepared. Place the required number of Sotalol Hydrochloride tablets in a suitable mortar, and comminute to a fine powder with a pestle. Add the Vehicle in small portions, and triturate to make a smooth paste. Add increasing volumes of the Vehicle to make a sotalol hydrochloride liquid that is pourable. Transfer the contents of the mortar, stepwise and quantitatively, to a calibrated bottle. Add enough of the Vehicle to bring to final volume, and mix well.

2 ASSAY

PROCEDURE

Mobile phase: Acetonitrile and 5 mM octanesulfonic acid (25:75), adjusted to a pH of 3.2. Pass through a nylon 66 filter of 0.45-µm pore size, and degas.

Standard solution: 20 µg/mL of USP Sotalol Hydrochloride RS in Mobile phase

Sample solution: Shake thoroughly by hand each bottle of Oral Suspension. Prepare 20 µg/mL of sotalol hydrochloride from Oral Suspension and Mobile phase. Centrifuge.

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 235 nm

Column: 3.0-mm × 15-cm; 5-µm packing L1

Flow rate: 0.4 mL/min

Injection volume: 10 µL

System suitability

Sample: Standard solution

[NOTE—The retention time for sotalol hydrochloride is about 5.1 min.]

Suitability requirements

Relative standard deviation: NMT 2.0% for replicate injections

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of sotalol hydrochloride (C₁₂H₂₀N₂O₃S · HCl) in the portion of Oral Suspension 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 Sotalol Hydrochloride RS in the Standard solution (µg/mL)

C_U = nominal concentration of sotalol hydrochloride in the Sample solution (µg/mL)

Acceptance criteria: 90.0%–110.0%

3 SPECIFIC TESTS

PH 〈791〉: 3.8–4.8

4 ADDITIONAL REQUIREMENTS

PACKAGING AND STORAGE: Package in tight, light-resistant containers. Store in a refrigerator or at controlled room temperature.

BEYOND-USE DATE: NMT 90 days after the date on which it was compounded when stored in a refrigerator or at controlled room temperature

LABELING: Label it to indicate that it is to be well shaken before use, and to state the Beyond-Use Date.

USP REFERENCE STANDARDS 〈11〉

USP Sotalol Hydrochloride RS