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d-Glucitol, 1-deoxy-1-(methylamino)-.
» Meglumine contains not less than 99.0 percent and not more than 100.5 percent of C7H17NO5, calculated on the dried basis.
Packaging and storage—Preserve in well-closed containers.
Completeness and color of solution—A solution (1 in 5) is clear, and its absorbance, determined in a 1-cm cell at 420 nm, with a suitable spectrophotometer, water being used as the blank, is not greater than 0.030.
Identification—Transfer about 250 mg to a dry, 50-mL centrifuge tube, add 500 mg of sodium metaperiodate, then add 5 mL of water rapidly in one portion. Allow to stand undisturbed: the solution instantly turns yellow and heat is produced. The color then changes from deep yellow to orange-brown (rust), and after 20 minutes, the rust-colored solution is cloudy. Then add 2 mL of 2.5 N sodium hydroxide: the mixture turns bright yellow and becomes clear.
Melting range 741: between 128 and 132.
Specific rotation 781S: between 15.7 and 17.3.
Test solution: 100 mg, undried, per mL, in water.
Loss on drying 731Dry about 1 g at 105 to constant weight: it loses not more than 1.0% of its weight.
Residue on ignition 281: not more than 0.1%.
Heavy metals 231Dissolve 1 g in 20 mL of water, add phenolphthalein TS, neutralize with 3 N hydrochloric acid, and dilute with water to 25 mL. The limit is 0.002%.
Absence of reducing substances—To 5 mL of a solution (1 in 20) add 5 mL of alkaline cupric tartrate TS, and heat to boiling: the color of the solution does not change.
Assay—Transfer about 500 mg of Meglumine, accurately weighed, to a conical flask, dissolve in about 40 mL of water, add 2 drops of methyl red TS, and titrate with 0.1 N hydrochloric acid VS. Each mL of 0.1 N hydrochloric acid is equivalent to 19.52 mg of C7H17NO5.
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Topic/QuestionContactExpert Committee
MonographRavi Ravichandran, Ph.D.
Principal Scientific Liaison
(SM42010) Monographs - Small Molecules 4
USP35–NF30 Page 3788