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Sucralfate Tablets
» Sucralfate Tablets contain not less than 90.0 percent and not more than 110.0 percent of the labeled amount of sucralfate (Al8(OH)16(C12H14O35S8)[Al(OH)3]x[H2O]y) corresponding to not less than 30.6 percent and not more than 37.4 percent of sucrose octasulfate (C12H14O35S8).
Packaging and storage— Preserve in tight containers.
USP Reference standards 11— USP Potassium Sucrose Octasulfate RS.
Identification—
A: The retention time of the sucrose octasulfate peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.
B: Shake a portion of finely powdered Tablets, equivalent to about 1 g of sucralfate, with 3 N hydrochloric acid, and filter: the solution so obtained meets the requirements of Identification test C under Sucralfate.
Disintegration 701: 15 minutes.
Uniformity of dosage units 905: meet the requirements.
Acid-neutralizing capacity— Weigh and finely powder not fewer than 20 Tablets. Transfer an accurately weighed portion of the powder, equivalent to about 250 mg of sucralfate, to a 250-mL screw-capped bottle, and proceed as directed in the test for Acid-neutralizing capacity under Sucralfate, beginning with “add 100.0 mL of 0.1 N hydrochloric acid”: not less than 12 mEq of acid is consumed.
Residual solvents 467: meet the requirements.
(Official January 1, 2007)
Assay—
Mobile phase, Standard preparation, and Chromatographic system— Prepare as directed in the Assay under Sucralfate.
Assay preparation— Weigh and finely powder not fewer than 20 Tablets. Transfer an accurately weighed portion of the powder, equivalent to about 450 mg of sucralfate, to a 35-mL centrifuge tube, and shake at a moderate rate on a vortex mixer. Proceed as directed for Assay preparation in the Assay under Sucralfate beginning with “While shaking, add 10.0 mL.”
Procedure— Proceed as directed for Procedure in the Assay under Sucralfate. 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 : (MDGRE05) Monograph Development-Gastrointestinal Renal and Endocrine
USP29–NF24 Page 2015
Pharmacopeial Forum : Volume No. 28(2) Page 369
Phone Number : 1-301-816-8251