Bethanechol Chloride Oral Suspension
Bethanechol Chloride Oral Suspension contains NLT 90.0% and NMT 110.0% of the labeled amount of bethanechol chloride (C7H17ClN2O2).
Prepare Bethanechol Chloride Oral Suspension 5 mg/mL as follows (see Pharmaceutical CompoundingNonsterile Preparations 795).
If using Bethanechol Chloride tablets, add to a suitable mortar and comminute to a fine powder, or add the Bethanechol Chloride powder to the mortar. Add about 20 mL of the Vehicle, and mix to a uniform paste. Add the Vehicle 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 sufficient Vehicle to final volume, and mix well.
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 Suspension 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 Suspension with Mobile phase to obtain a nominal concentration of 500 µg/mL of bethanechol chloride.
Detector: UV 200 nm
Column: 4.6-mm × 25-cm; 5-µm packing L11
Flow rate: 0.7 mL/min
Injection size: 20 µL
Sample: Standard solution
[NoteThe retention time for bethanechol chloride is about 3 min. ]
Relative standard deviation: NMT 3.1% for replicate injections
Samples: Standard solution and Sample solution
Calculate the percentage of the labeled amount of bethanechol chloride (C7H17ClN2O2) in the volume of Oral Suspension taken:
Result = (rU/rS) × (CS/CU) × 100
Acceptance criteria: 90.0%110.0%
• pH 791: 3.94.9
• Packaging and Storage: Package in tight, light-resistant containers. Store at room temperature, or in a cold place.
• Labeling: Label it to state that it is to be well shaken, and to state the Beyond-Use Date.
• Beyond-Use Date: NMT 60 days after the day on which it was compounded.
• USP Reference Standards 11
Auxiliary Information Please check for your question in the FAQs before contacting USP.
USP35NF30 Page 2352Pharmacopeial Forum: Volume No. 32(1) Page 57