Terbutaline Oral Suspension
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.
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.
Detector: UV 278 nm
Column: 3.9-mm × 30-cm; 10-µm microphenyl packing L11
Flow rate: 2 mL/min
Injection size: 20 µL
Sample: Standard solution
[NoteThe retention time for the terbutaline peak is 5 min. ]
Relative standard deviation: NMT 2.2% for replicate injections
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%
• 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
• USP Reference Standards 11
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USP35NF30 Page 4792Pharmacopeial Forum: Volume No. 35(1) Page 97