Dihydroxyaluminum Aminoacetate Magma
» 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.
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 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.
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.
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USP35NF30 Page 2913