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Dihydroxyaluminum Sodium Carbonate Tablets
» Dihydroxyaluminum Sodium Carbonate Tablets contain not less than 90.0 percent and not more than 110.0 percent of the labeled amount of CH2AlNaO5.
Packaging and storage— Preserve in well-closed containers.
Labeling— Label the Tablets to indicate that they are to be chewed before swallowing.
Identification— A 1 in 10 suspension of powdered Tablets in 3 N hydrochloric acid responds to the tests for Aluminum 191 and for Sodium 191.
Uniformity of dosage units 905: meet the requirements.
Acid-neutralizing capacity 301— Not less than 5 mEq of acid is consumed by the minimum single dose recommended in the labeling, and not less than the number of mEq calculated by the formula:
0.8(0.0278D),
in which 0.0278 is the theoretical acid-neutralizing capacity, in mEq, of CH2AlNaO5, and D is the quantity, in mg, of CH2AlNaO5 in the specimen tested, based on the labeled quantity.
Residual solvents 467: meet the requirements.
(Official January 1, 2007)
Assay—
Edetate disodium titrant— Dissolve 18.6 g of edetate disodium in water to make 500 mL, and standardize as directed in the Assay under Ammonium Alum.
Procedure— Weigh and finely powder not less than 20 Tablets. Transfer an accurately weighed portion of the powder, equivalent to about 300 mg of dihydroxyaluminum sodium carbonate, to a 250-mL beaker, and proceed as directed in the Assay under Dihydroxyaluminum Sodium Carbonate, beginning with “add 10 mL of 2 N sulfuric acid.” Each mL of 0.1 M Edetate disodium titrant is equivalent to 14.40 mg of CH2AlNaO5.
Auxiliary Information— Staff Liaison : Elena Gonikberg, Ph.D., Scientist
Expert Committee : (MDGRE05) Monograph Development-Gastrointestinal Renal and Endocrine
USP29–NF24 Page 713
Pharmacopeial Forum : Volume No. 29(6) Page 1873
Phone Number : 1-301-816-8251