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Terbutaline Sulfate Tablets
» Terbutaline Sulfate Tablets contain not less than 90.0 percent and not more than 110.0 percent of the labeled amount of (C12H19NO3)2·H2SO4.
Packaging and storage— Preserve in tight containers, at controlled room temperature.
Identification— The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.
Dissolution, Procedure for a Pooled Sample 711
Medium: water; 900 mL.
Apparatus 1: 100 rpm.
Time: 45 minutes.
Procedure— Determine the amount of (C12H19NO3)2·H2SO4 dissolved, employing the procedure set forth in the Assay, making any necessary modifications.
Tolerances— Not less than 75% (Q) of the labeled amount of (C12H19NO3)2·H2SO4 is dissolved in 45 minutes.
Uniformity of dosage units 905: meet the requirements.
Residual solvents 467: meet the requirements.
(Official January 1, 2007)
Ion-pair solution, Mobile phase, System suitability solution, and Chromatographic system— Proceed as directed in the Assay under Terbutaline Sulfate.
Standard preparation— Dissolve an accurately weighed quantity of USP Terbutaline Sulfate RS in Mobile phase, and dilute quantitatively, and stepwise if necessary, with Mobile phase to obtain a solution having a known concentration of about 1 mg per mL. Transfer 10.0 mL of the solution so obtained to a 100-mL volumetric flask, add 10 mL of 0.05 N sulfuric acid, dilute with water to volume, and mix.
Assay preparation— Weigh and finely powder not fewer than 20 Tablets. Transfer an accurately weighed portion of the powder, equivalent to about 10 mg of terbutaline sulfate, to a 100-mL volumetric flask. Add 10 mL of 0.05 N sulfuric acid and 20 mL of water, and shake for 15 minutes. Dilute with water to volume, mix, and filter.
Procedure— Separately inject equal volumes (about 20 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks. Calculate the quantity, in mg, of terbutaline sulfate [(C12H19NO3)2·H2SO4] in the portion of Tablets taken by the formula:
100C(rU / rS)
in which C is the concentration, in mg per mL, of USP Terbutaline Sulfate RS in the Standard preparation; and rU and rS are the terbutaline peak responses obtained from the Assay preparation and the Standard preparation, respectively.
Auxiliary Information— Staff Liaison : Daniel K. Bempong, Ph.D., Scientist
Expert Committee : (MDPS05) Monograph Development-Pulmonary and Steroids
USP29–NF24 Page 2083
Pharmacopeial Forum : Volume No. 31(1) Page 76
Phone Number : 1-301-816-8143