Terbutaline Sulfate Compounded Oral Suspension

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

DOWNLOAD PDF HERE

1 DEFINITION

Terbutaline Sulfate Compounded Oral Suspension contains NLT 90.0% and NMT 110.0% of the labeled amount of terbutaline sulfate [(C₁₂H₁₉NO₃)₂ · H₂SO₄]. Prepare Terbutaline Sulfate Compounded Oral Suspension 1 mg/mL as follows (see Pharmaceutical Compounding— Nonsterile Preparations 〈795〉).

^a Syrup, NF, containing 0.2% sodium benzoate.

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 sulfate 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.

2 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 Oral 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

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 278 nm

Column: 3.9-mm × 30-cm; 10-µm microphenyl packing L11

Flow rate: 2 mL/min

Injection volume: 20 µL

System suitability

Sample: Standard solution

[NOTE—The retention time for the terbutaline sulfate 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 terbutaline sulfate [(C₁₂H₁₉NO₃)₂ · H₂SO₄] in the portion of Oral Suspension taken:

Result = (r_U/r_S) × (C_S/C_U) × 100

r_U = peak response from the Sample solution

r_S = peak response from the Standard solution

C_S = concentration of USP Terbutaline Sulfate RS in the Standard solution (µg/mL)

C_U = nominal concentration of terbutaline sulfate in the Sample solution (µg/mL)

Acceptance criteria: 90.0%–110.0%

3 ADDITIONAL REQUIREMENTS

PACKAGING AND STORAGE: Package in tight, light-resistant containers. Store in a refrigerator.

BEYOND-USE DATE: NMT 30 days after the date on which it was compounded when stored in a refrigerator

LABELING: Label it to state that it is to be well shaken before use, and to state the Beyond-Use Date.

USP REFERENCE STANDARDS 〈11〉

USP Terbutaline Sulfate RS