» Magaldrate Tablets contain not less than 90.0 percent and not more than 110.0 percent of the labeled amount of magaldrate [Al5Mg10(OH)31(SO4)2].
Packaging and storage Preserve in well-closed containers.
Labeling Label the Tablets to indicate whether they are to be swallowed or to be chewed.
Identification Transfer a quantity of powdered Tablets, equivalent to about 2 g of magaldrate, to a 100-mL centrifuge tube. Add about 60 mL of water, cap, and shake for 3 minutes. Centrifuge the suspension, and discard the supernatant. Repeat the washing with three more 60-mL portions of water. Transfer the residue to a 250-mL beaker, and heat on a steam bath to dryness: the residue so obtained meets the requirements of the Identification tests under Magaldrate.
Microbial enumeration tests 61 and Tests for specified microorganisms 62 Tablets meet the requirements of the test for absence of Escherichia coli.
Disintegration 701: 2 minutes, for Tablets labeled to be swallowed.
Uniformity of dosage units 905: meet the requirements for Weight Variation.
Acid-neutralizing capacity Proceed as directed under Acid-Neutralizing Capacity 301. The acid consumed by the minimum single dose recommended in the labeling is not less than 5 mEq, and not less than the number of mEq calculated by the formula:
0.8(0.0282M)in which 0.0282 is the theoretical acid-neutralizing capacity, in mEq per mg, of magaldrate; and M is the quantity, in mg, of the labeled amount of magaldrate.
Magnesium hydroxide content
Test preparation Weigh and finely powder not fewer than 20 Tablets. Transfer an accurately weighed portion of the powder, equivalent to about 1 g of magaldrate, to a 100-mL volumetric flask, add 30 mL of dilute hydrochloric acid (1 in 10), shake for 15 minutes, dilute with water to volume, and mix.
Procedure Transfer 10.0 mL of Test preparation to a 400-mL beaker, and proceed as directed in the test for Magnesium hydroxide content under Magaldrate, beginning with and dilute with water to about 200 mL. Not less than 492 mg and not more than 666 mg of magnesium hydroxide [Mg(OH)2] per g of the labeled amount of magaldrate is found.
Aluminum hydroxide content
Test preparation Prepare as directed in the test for Magnesium hydroxide content.
Procedure Transfer 10.0 mL of Test preparation and 20 mL of water to a 250-mL beaker, and proceed as directed for Procedure in the test for Aluminum hydroxide content under Magaldrate, beginning with Add, with stirring, 25.0 mL of Edetate disodium titrant. Not less than 321 mg and not more than 459 mg of aluminum hydroxide [Al(OH)3] per g of the labeled amount of magaldrate is found.
Assay Weigh and finely powder not fewer than 20 Tablets. Transfer an accurately weighed portion of the powder, equivalent to about 6 g of magaldrate, to a 200-mL volumetric flask. Add 100.0 mL of 2 N hydrochloric acid VS, and swirl by mechanical means for 30 minutes. Dilute with water to volume, mix, and filter. Transfer 100.0 mL of the filtrate to a beaker. Titrate the excess acid with 1 N sodium hydroxide VS to a pH of 3.0, determined potentiometrically. Perform a blank determination (see Residual Titrations under Titrimetry 541). Each mL of 2 N hydrochloric acid is equivalent to 70.80 mg of Al5Mg10(OH)31(SO4)2.
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USP32NF27 Page 2824