Meglumine
;)
D-Glucitol,1-deoxy-1-(methylamino)-.
1-Deoxy-1-(methylamino)-D-glucitol [6284-40-8].
»Meglumine contains not less than 99.0percent and not more than 100.5percent of C7H17NO5,calculated on the dried basis.
Packaging and storage—
Preserve in well-closed containers.
Completeness and color of solution—
Asolution (1in 5)is clear,and its absorbance,determined in a 1-cm cell at 420nm,with a suitable spectrophotometer,water being used as the blank,is not greater than 0.030.
Identification—
Transfer about 250mg to a dry,50-mLcentrifuge tube,add 500mg of sodium metaperiodate,then add 5mLof 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 20minutes,the rust-colored solution is cloudy.Then add 2mLof 2.5Nsodium hydroxide:the mixture turns bright yellow and becomes clear.
Specific rotation á781Sñ:
between -15.7
and -17.3.
and -17.3.
Test solution:
100mg,undried,per mL,in water.
Loss on drying á731ñ—
Dry about 1g at 105to constant weight:it loses not more than 1.0%of its weight.
to constant weight:it loses not more than 1.0%of its weight.
Residue on ignition á281ñ:
not more than 0.1%.
Heavy metals á231ñ—
Dissolve 1g in 20mLof water,add phenolphthalein TS,neutralize with 3Nhydrochloric acid,and dilute with water to 25mL.The limit is 0.002%.
Absence of reducing substances—
To 5mLof a solution (1in 20)add 5mLof alkaline cupric tartrate TS,and heat to boiling:the color of the solution does not change.
Assay—
Transfer about 500mg of Meglumine,accurately weighed,to a conical flask,dissolve in about 40mLof water,add 2drops of methyl red TS,and titrate with 0.1Nhydrochloric acid VS.Each mLof 0.1Nhydrochloric acid is equivalent to 19.52mg of C7H17NO5.
Auxiliary Information—
Staff Liaison:Andrzej Wilk,Ph.D.,Senior Scientific Associate
Expert Committee:(RMI)Radiopharmaceuticals and Medical Imaging Agents
USP28–NF23Page 1201
Phone Number:1-301-816-8305