Bethanechol Chloride 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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1 DEFINITION

Bethanechol Chloride Compounded Oral Solution contains NLT 90.0% and NMT 110.0% of the labeled amount of bethanechol chloride (C₇H₁₇ClN₂O₂).

Prepare Bethanechol Chloride Compounded Oral Solution 5 mg/mL as follows (see Pharmaceutical Compounding—Nonsterile Preparations 〈795〉):

Bethanechol Chloride 500 mg

Vehicle for Oral Solution (regular or sugar-free), NF, a sufficient quantity to make 100 mL

Add Bethanechol Chloride powder and about 20 mL of Vehicle for Oral Solution to a mortar, and mix. Add the Vehicle for Oral Solution in small portions almost to volume, and mix thoroughly after each addition. Transfer the contents of the mortar, stepwise and quantitatively, to a calibrated bottle. Add enough Vehicle for Oral Solution to bring to final volume, and mix well.

2 ASSAY

Procedure

Mobile phase: Acetonitrile and water (33:67)

Standard solution: 500 µg/mL of USP Bethanechol Chloride RS in Mobile phase

Sample solution: Agitate the container of Oral Solution for 30 min on a rotating mixer, remove a 10-mL sample, and store in a clear glass vial at −70° until analyzed. At the time of analysis, remove the sample from the freezer, allow it to reach room temperature, and mix with a vortex mixer for 30 s. Dilute a suitable volume of Oral Solution with Mobile phase to obtain a nominal concentration of 500 µg/mL of bethanechol chloride.

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 200 nm

Column: 4.6-mm × 25-cm; 5-µm packing L11

Flow rate: 0.7 mL/min

Injection volume: 20 µL

System suitability

Sample: Standard solution

[Note—The retention time of bethanechol chloride is about 3 min.]

Suitability requirements

Relative standard deviation: NMT 3.1% for replicate injections

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of bethanechol chloride (C₇H₁₇ClN₂O₂) in the portion of Oral 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 Bethanechol Chloride RS in the Standard solution (µg/mL)

Cᵤ = nominal concentration of bethanechol chloride in the Sample solution (µg/mL)

Acceptance criteria: 90.0%–110.0%

3 SPECIFIC TESTS

pH 〈791〉: 3.9–4.9

4 ADDITIONAL REQUIREMENTS

Packaging and Storage: Package in tight, light-resistant containers. Store at room temperature or in a refrigerator.

Beyond-Use Date: NMT 60 days after the day on which it was compounded when stored at room temperature or in a refrigerator

Labeling: Label it to state the Beyond-Use Date.

USP Reference Standards 〈11〉

USP Bethanechol Chloride RS