Sucralfate Tablets
»Sucralfate Tablets contain not less than 90.0percent and not more than 110.0percent of the labeled amount of sucralfate (Al8(OH)16(C12H14O35S8)[Al(OH)3]x[H2O]y)corresponding to not less than 30.6percent and not more than 37.4percent of sucrose octasulfate (C12H14O35S8).
Packaging and storage— Preserve in tight containers.
USP Reference standards á11ñ— USP Potassium Sucrose Octasulfate RS.
Identification—
A: The retention time of the sucrose octasulfate peak in the chromatogram of theAssay preparation corresponds to that in the chromatogram of theStandard preparation,as obtained in theAssay.
B: Shake a portion of finely powdered Tablets,equivalent to about 1g of sucralfate,with 3Nhydrochloric acid,and filter:the solution so obtained meets the requirements ofIdentification testCunderSucralfate.
Uniformity of dosage units á905ñ: meet the requirements.
Acid-neutralizing capacity— Weigh and finely powder not fewer than 20Tablets.Transfer an accurately weighed portion of the powder,equivalent to about 250mg of sucralfate,to a 250-mLscrew-capped bottle,and proceed as directed in the test for Acid-neutralizing capacityunderSucralfate,beginning with “add 100.0mLof 0.1Nhydrochloric acid”:not less than 12mEq of acid is consumed.
Assay—
Mobile phase,Standard preparation,and Chromatographic system— Prepare as directed in theAssay underSucralfate.
Assay preparation— Weigh and finely powder not fewer than 20Tablets.Transfer an accurately weighed portion of the powder,equivalent to about 450mg of sucralfate,to a 35-mLcentrifuge tube,and shake at a moderate rate on a vortex mixer.Proceed as directed forAssay preparation in theAssay underSucralfate beginning with “While shaking,add 10.0mL.”
Procedure— Proceed as directed forProcedure in theAssay underSucralfate.Calculate the quantity,in mg,of sucrose octasulfate (C12H14O35S8)in the portion of Tablets taken by the formula:
(974.75/1287.53)(25C)(rU/rS),
in which the terms are as defined therein.
Auxiliary Information— Staff Liaison:Elena Gonikberg,Ph.D.,Scientist
Expert Committee:(PA4)Pharmaceutical Analysis 4
USP28–NF23Page 1811
Pharmacopeial Forum:Volume No.28(2)Page 369
Phone Number:1-301-816-8251