Dihydroxyaluminum Aminoacetate Magma
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This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
Dihydroxyaluminum Aminoacetate Magma is a suspension that contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of C2H6AlNO4.
1 Packaging and storage—
Preserve in tight containers, and protect from freezing.
2 Identication—
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 lter: the ltered solution responds to the Identication tests under Dihydroxyaluminum Aminoacetate.
Microbial enumeration tests 〈61〉 and Tests for specified microorganisms 〈62〉—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 C2H6AlNO4, and D is the quantity, in mg, of C2H6AlNO4 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.
3 Assay—
Edetate disodium titrant—Prepare and standardize as directed in the Assay under Ammonium Alum.
Procedure—[Note—Shake 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 ask, dilute with water to volume, mix, and lter, 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.”
