Dried Aluminum Hydroxide Gel Tablets
»Dried Aluminum Hydroxide Gel Tablets contain not less than 90.0percent and not more than 110.0percent of the labeled amount of aluminum hydroxide [Al(OH)3].
Packaging and storage— Preserve in well-closed containers.
Labeling— Tablets may be labeled to state the aluminum hydroxide content in terms of the equivalent amount of dried aluminum hydroxide gel,on the basis that each mg of dried gel is equivalent to 0.765mg of Al(OH)3.
Identification—
A: Place a quantity of finely ground Tablets,equivalent to about 500mg of aluminum hydroxide,in a flask equipped with a stopper and glass tubing,the tip of which is immersed in calcium hydroxide TSin a test tube.Add 5mLof 3Nhydrochloric acid to the flask,and immediately insert the stopper:gas evolves in the flask and a precipitate is formed in the test tube.
B: The solution remaining in the flask responds to the tests for Aluminum á191ñ.
Disintegration á701ñ: 10minutes,simulated gastric fluid TSbeing substituted for water in the test.
Uniformity of dosage units á905ñ: meet the requirements for Weight Variation.
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 55.0%of the expected mEq value,calculated from the labeled quantity of Al(OH)3,is obtained.Each mg of Al(OH)3has an expected acid-neutralizing capacity value of 0.0385mEq.
Assay—
Edetate disodium titrant— Prepare and standardize as directed in the Assayunder Ammonium Alum.
Procedure— Weigh and finely powder not fewer than 20Tablets.Weigh accurately a portion of the powder,equivalent to about 1.2g of aluminum hydroxide,add 15mLof hydrochloric acid,and heat until dissolved.Dilute with water to about 100mL,mix,and filter quantitatively into a 500-mLvolumetric flask,washing the filter with water.Proceed as directed in the Assayunder Dried Aluminum Hydroxide Gel,beginning with “dilute with water to volume.”Each mLof 0.05MEdetate disodium titrantis equivalent to 3.900mg of Al(OH)3.
Auxiliary Information— Staff Liaison:Elena Gonikberg,Ph.D.,Scientist
Expert Committee:(PA4)Pharmaceutical Analysis 4
USP28–NF23Page 93
Phone Number:1-301-816-8251