Tolmetin Sodium Tablets, chemical structure, molecular formula, Reference Standards
Tolmetin Sodium Tablets
»Tolmetin Sodium Tablets contain an amount of tolmetin sodium equivalent to not less than 90.0percent and not more than 110.0percent of the labeled amount of tolmetin (C15H15NO3).
Packaging and storage
Preserve in well-closed containers.
USP Reference standards á11ñ
USP Tolmetin Sodium RS.
Aquantity of finely powdered Tablets,equivalent to about 10mg of tolmetin,responds to Identificationtest Aunder Tolmetin Sodium Capsules.
The chromatogram of the Assay preparationobtained as directed in the Assayexhibits a major peak for tolmetin,the retention time of which corresponds to that exhibited in the chromatogram of the Standard preparationobtained as directed in the Assay.
,Apparatus,Time,and ProcedureProceed as directed in the test for Dissolutionunder Tolmetin Sodium Capsules.
Not less than 75%(Q)of the labeled amount of C15H15NO3is dissolved in 30minutes.
Uniformity of dosage units á905ñ:
meet the requirements.
pH2.7buffer solution,Mobile phase,Solvent mixture,Standard preparation,Resolution solution,and Chromatographic system
Prepare as directed in the Assayunder Tolmetin Sodium Capsules.
Weigh and finely powder not less than 20Tablets.Transfer an accurately weighed portion of the powder,equivalent to about 60mg of tolmetin,to a 100-mLvolumetric flask.Add about 75mLof Solvent mixture,and shake by mechanical means for 30minutes.Dilute with Solvent mixtureto volume,mix,and filter through a filter having a porosity of 0.45µm or less.
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 C15H15NO3in the portion of Tablets taken by the formula:
in which Cis the concentration,in mg per mL,of USP Tolmetin Sodium RSin the Standard preparation,257.29and 279.27are the molecular weights of tolmetin and anhydrous tolmetin sodium,respectively,and rUand rSare the peak responses obtained from the Assay preparationand the Standard preparation,respectively.
Staff Liaison:Daniel K.Bempong,Ph.D.,Scientist
Expert Committee:(PA2)Pharmaceutical Analysis 2
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