Terbutaline Oral Suspension
DEFINITION
Terbutaline Oral Suspension contains NLT 90.0% and NMT 110.0% of the labeled content of terbutaline sulfate [(C12H19NO3)2·H2SO4]. Prepare Terbutaline Oral Suspension (1 mg/mL) as follows (see Pharmaceutical CompoundingNonsterile Preparations 795).
Calculate the required quantity of each ingredient for the total amount to be prepared. If using tablets, place the required number of tablets in a suitable mortar, and comminute the tablets to a fine powder or add Terbutaline Sulfate powder. Add the Syrup, NF, to make a terbutaline suspension that is pourable. Transfer the contents of the mortar, stepwise and quantitatively, to a calibrated bottle. Add enough of the Syrup, NF, to bring to final volume, and mix well.
ASSAY
• Procedure
Mobile phase:
A solution of methanol and 20 mM monobasic potassium phosphate (2:23), adjusted with phosphoric acid to a pH of 3.6. Filter and degas.
Standard stock solution:
5 mg/mL of USP Terbutaline Sulfate RS in methanol
Standard solution:
Transfer 0.2 mL of Standard stock solution to a 100-mL volumetric flask, dilute with water to volume to obtain a solution containing 10 µg/mL of terbutaline sulfate, and pass through a suitable filter of 0.22-µm pore size.
Sample solution:
Shake thoroughly by hand each bottle of Oral Suspension. Accurately pipet 1.0 mL to a 10-mL volumetric flask. Dilute with Mobile phase to volume to obtain a nominal concentration of 100 µg/mL of terbutaline sulfate. Extract terbutaline sulfate from the suspension with methanol. Accurately pipet 1 mL of Oral Suspension and 3 mL of Mobile phase in the barrel of a 5-mL plastic syringe. Shake, and pass through a suitable filter of 0.22-µm pore size into a 10-mL volumetric flask. Repeat the process with an additional 2 mL of methanol. Bring to a final volume of 10 mL with Mobile phase to obtain a nominal concentration of 10 µg/mL of terbutaline sulfate.
Chromatographic system
Mode:
LC
Detector:
UV 278 nm
Column:
3.9-mm × 30-cm; 10-µm microphenyl packing L11
Flow rate:
2 mL/min
Injection size:
20 µL
System suitability
Sample:
Standard solution
[NoteThe retention time for the terbutaline peak is 5 min. ]
Suitability requirements
Relative standard deviation:
NMT 2.2% for replicate injections
Analysis
Samples:
Standard solution and Sample solution
Calculate the percentage of the labeled amount of (C12H19NO3)2·H2SO4 in the volume of Oral Suspension taken:
Result = (rU/rS) × (CS/CU) × 100
Acceptance criteria:
90.0%110.0%
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Package in tight, light-resistant containers. Store at controlled cold temperature.
• Labeling:
Label it to state that it is to be well shaken before use, and to state the Beyond-Use Date.
• Beyond-Use Date:
NMT 30 days after the date on which it was compounded when stored at controlled cold temperature
Auxiliary Information
Please check for your question in the FAQs before contacting USP.
USP35NF30 Page 4792
Pharmacopeial Forum: Volume No. 35(1) Page 97
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