Meglumine (me' gloo meen). » Meglumine contains not less than 99.0 percent and not more than 100.5 percent of C7H17NO5, calculated on the dried basis. Packaging and storagePreserve in well-closed containers. Completeness and color of solutionA 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. IdentificationTransfer 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. 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 substancesTo 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. AssayTransfer 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. Auxiliary InformationPlease check for your question in the FAQs before contacting USP.
USP35NF30 Page 3788 |