Bethanechol Chloride Oral Suspension
DEFINITION
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.
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 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.
Chromatographic system
Mode:
LC
Detector:
UV 200 nm
Column:
4.6-mm × 25-cm; 5-µm packing L11
Flow rate:
0.7 mL/min
Injection size:
20 µL
System suitability
Sample:
Standard solution
[NoteThe retention time for 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 volume of Oral Suspension taken:
Result = (rU/rS) × (CS/CU) × 100
Acceptance criteria:
90.0%110.0%
SPECIFIC TESTS
• pH 791:
3.94.9
ADDITIONAL REQUIREMENTS
• 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.
Auxiliary Information
Please check for your question in the FAQs before contacting USP.
USP35NF30 Page 2352
Pharmacopeial Forum: Volume No. 32(1) Page 57
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