Dihydroxyaluminum Sodium Carbonate Tablets
»Dihydroxyaluminum Sodium Carbonate Tablets contain not less than 90.0percent and not more than 110.0percent 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— A1in 10suspension of powdered Tablets in 3Nhydrochloric acid responds to the tests for Aluminum á191ñand for Sodium á191ñ.
Uniformity of dosage units á905ñ: meet the requirements.
Acid-neutralizing capacity á301ñ— Not less than 5mEq 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 0.0278is the theoretical acid-neutralizing capacity,in mEq,of CH2AlNaO5,and Dis the quantity,in mg,of CH2AlNaO5in the specimen tested,based on the labeled quantity.
Assay—
Edetate disodium titrant— Dissolve 18.6g of edetate disodium in water to make 500mL,and standardize as directed in the Assayunder Ammonium Alum.
Procedure— Weigh and finely powder not less than 20Tablets.Transfer an accurately weighed portion of the powder,equivalent to about 300mg of dihydroxyaluminum sodium carbonate,to a 250-mLbeaker,and proceed as directed in the Assayunder Dihydroxyaluminum Sodium Carbonate,beginning with “add 10mLof 2Nsulfuric acid.”Each mLof 0.1M Edetate disodium titrantis equivalent to 14.40mg of CH2AlNaO5.
Auxiliary Information— Staff Liaison:Elena Gonikberg,Ph.D.,Scientist
Expert Committee:(PA4)Pharmaceutical Analysis 4
USP28–NF23Page 654
Pharmacopeial Forum:Volume No.29(6)Page 1873
Phone Number:1-301-816-8251