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Magnesium Trisilicate Tablets
» Magnesium Trisilicate Tablets contain not less than 90.0 percent and not more than 110.0 percent of the labeled amount of Mg2Si3O8.
Packaging and storage— Preserve in well-closed containers.
Identification—
A: Powder 1 Tablet, add 10 mL of 3 N hydrochloric acid and 5 drops of methyl red TS, heat to boiling, add 6 N ammonium hydroxide until the color of the solution changes to deep yellow, then continue boiling for 2 minutes, and filter: the filtrate so obtained responds to the tests for Magnesium 191.
B: Wash the solids on the filter obtained in Identification test A with hot ammonium chloride solution (1 in 50), add 10 mL of 3 N hydrochloric acid, and filter. Transfer the filter paper and contents to a small platinum dish, ignite, cool in a desiccator, and weigh. Moisten the residue with water, and add 6 mL of hydrofluoric acid. Evaporate to dryness, ignite for 5 minutes, cool in a desiccator, and weigh: a loss of more than 10% in relation to the weight of the residue from the initial ignition indicates SiO2.
Disintegration 701: 10 minutes, simulated gastric fluid TS being substituted for water in the test.
Uniformity of dosage units 905: meet the requirements.
Acid-neutralizing capacity 301 Not less than 5 mEq of acid is consumed by the minimum single dose recommended in the labeling.
Residual solvents 467: meet the requirements.
(Official January 1, 2007)
Assay— Weigh and finely powder not fewer than 20 Tablets. Transfer an accurately weighed portion of the powder, equivalent to about 1 g of magnesium trisilicate, to a beaker, add 20 mL of water, and slowly add 40 mL of 3 N hydrochloric acid, with mixing. Heat the mixture to boiling, cool, and filter into a 200-mL volumetric flask. Wash the beaker with water, adding the washings to the filter. Add water to volume, and mix. Transfer 20.0 mL of this solution to a 400-mL beaker, add 180 mL of water and 20 mL of triethanolamine, and stir. Add 10 mL of ammonia–ammonium chloride buffer TS and 3 drops of an eriochrome black indicator solution prepared by dissolving 200 mg of eriochrome black T in a mixture of 15 mL of triethanolamine and 5 mL of dehydrated alcohol, and mix. Cool the solution to between 3 and 4 by immersion of the beaker in an ice bath, then remove, and titrate with 0.05 M edetate disodium VS to a blue endpoint. Perform a blank determination, substituting 20 mL of water for the assay solution, and make any necessary correction. Each mL of 0.05 M edetate disodium consumed is equivalent to 6.521 mg of Mg2Si3O8.
Auxiliary Information— Staff Liaison : Elena Gonikberg, Ph.D., Scientist
Expert Committee : (MDGRE05) Monograph Development-Gastrointestinal Renal and Endocrine
USP29–NF24 Page 1304
Phone Number : 1-301-816-8251