Terbutaline Sulfate Tablets »Terbutaline Sulfate Tablets contain not less than 90.0percent and not more than 110.0percent of the labeled amount of (C12H19NO3)2·H2SO4. Packaging and storage— Preserve in tight containers,at controlled room temperature. USP Reference standards á11ñ USP Terbutaline Sulfate RS.USP Terbutaline Sulfate Related Compound A RS. Identification— The retention time of the major peak in the chromatogram of the Assay preparationcorresponds to that in the chromatogram of the Standard preparation,as obtained in the Assay. Dissolution,Procedure for a Pooled Sample á711ñ Medium: water;900mL. Apparatus 1: 100rpm. Time: 45minutes. Procedure— Determine the amount of (C12H19NO3)2·H2SO4dissolved,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·H2SO4is dissolved in 45minutes. Uniformity of dosage units á905ñ: meet the requirements. Assay— Ion-pair solution,Mobile phase,System suitability solution,and Chromatographic system— Proceed as directed in the Assayunder Terbutaline Sulfate. Standard preparation— Dissolve an accurately weighed quantity of USP Terbutaline Sulfate RSin Mobile phase,and dilute quantitatively,and stepwise if necessary,with Mobile phaseto obtain a solution having a known concentration of about 1mg per mL.Transfer 10.0mLof the solution so obtained to a 100-mLvolumetric flask,add 10mLof 0.05Nsulfuric acid,dilute with water to volume,and mix. Assay preparation— Weigh and finely powder not fewer than 20Tablets.Transfer an accurately weighed portion of the powder,equivalent to about 10mg of terbutaline sulfate,to a 100-mLvolumetric flask.Add 10mLof 0.05Nsulfuric acid and 20mLof water,and shake for 15minutes.Dilute with water to volume,mix,and filter. Procedure— Separately inject equal volumes (about 20µL)of the Standard preparationand the Assay preparationinto 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 Cis the concentration,in mg per mL,of USP Terbutaline Sulfate RSin the Standard preparation;and rUand rSare the terbutaline peak responses obtained from the Assay preparationand the Standard preparation,respectively. Auxiliary Information— Staff Liaison:Karen A Russo,Ph.D.,Scientist Expert Committee:(PA1)Pharmaceutical Analysis 1 USP28–NF23Page 1871 Pharmacopeial Forum:Volume No.30(1)Page 188 Phone Number:1-301-816-8379