Dihydroxyaluminum Aminoacetate Magma
»Dihydroxyaluminum Aminoacetate Magma is a suspension that contains not less than 90.0percent and not more than 110.0percent of the labeled amount of C2H6AlNO4.
Packaging and storage— Preserve in tight containers,and protect from freezing.
Identification— Dilute a volume of Magma,equivalent to about 1g of dihydroxyaluminum aminoacetate,with water to 25mL,add hydrochloric acid,dropwise,until a solution results,and then filter:the filtered solution responds to the Identificationtests under Dihydroxyaluminum Aminoacetate.
Microbial limits á61ñ— The total bacterial count does not exceed 100cfu per mL,and the test for Escherichia coliis negative.
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(0.0148D),
in which 0.0148is the theoretical acid-neutralizing capacity,in mEq,of C2H6AlNO4,and Dis the quantity,in mg,of C2H6AlNO4in the specimen tested,based on the labeled quantity.
pHá791ñ: between 6.5and 7.5,in a dilution in water,equivalent to about 1g of dihydroxyaluminum aminoacetate in 25mL.
Assay—
Edetate disodium titrant— Prepare and standardize as directed in the Assayunder Ammonium Alum.
Procedure— [NOTE—Shake the container by mechanical means for 1hour before removing the specimen.]Weigh accurately in a tared beaker a quantity of Dihydroxyaluminum Aminoacetate Magma,equivalent to about 2.5g of dihydroxyaluminum aminoacetate,add 15mLof hydrochloric acid,and boil gently for about 5minutes.Cool,transfer the solution with the aid of water to a 500-mLvolumetric flask,dilute with water to volume,mix,and filter,if necessary,to obtain a clear solution.Proceed as directed in the Assayunder Dihydroxyaluminum Aminoacetate,beginning with “Transfer 20.0mLof this solution.”
Auxiliary Information— Staff Liaison:Elena Gonikberg,Ph.D.,Scientist
Expert Committee:(PA4)Pharmaceutical Analysis 4
USP28–NF23Page 653
Phone Number:1-301-816-8251