Packaging and storage
Preserve in tight containers, and protect from freezing.
Identification
Dilute a volume of Magma, equivalent to about 1 g of dihydroxyaluminum aminoacetate, with water to 25 mL, add hydrochloric acid, dropwise, until a solution results, and then filter: the filtered solution responds to the
Identification tests under
Dihydroxyaluminum Aminoacetate.
Microbial limits 61
The total bacterial count does not exceed 100 cfu per mL, and the test for
Escherichia coli is negative.
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(0.0148D),
in which 0.0148 is the theoretical acid-neutralizing capacity, in mEq, of C
2H
6AlNO
4, and
D is the quantity, in mg, of C
2H
6AlNO
4 in the specimen tested, based on the labeled quantity.
pH 791:
between 6.5 and 7.5, in a dilution in water, equivalent to about 1 g of dihydroxyaluminum aminoacetate in 25 mL.
Assay
Edetate disodium titrant
Prepare and standardize as directed in the
Assay under
Ammonium Alum.
Procedure
[NOTEShake the container by mechanical means for 1 hour before removing the specimen.
] Weigh accurately in a tared beaker a quantity of Dihydroxyaluminum Aminoacetate Magma, equivalent to about 2.5 g of dihydroxyaluminum aminoacetate, add 15 mL of hydrochloric acid, and boil gently for about 5 minutes. Cool, transfer the solution with the aid of water to a 500-mL volumetric flask, dilute with water to volume, mix, and filter, if necessary, to obtain a clear solution. Proceed as directed in the
Assay under
Dihydroxyaluminum Aminoacetate, beginning with Transfer 20.0 mL of this solution.