Norepinephrine Bitartrate
;)
1,2-Benzenediol,4-(2-amino-1-hydroxyethyl)-,(R)-,[R-(R*,R*)]-2,3-dihydroxybutanedioate (1:1)(salt),monohydrate.
(-)-a-(Aminomethyl)-3,4-dihydroxybenzyl alcohol tartrate (1:1)(salt),monohydrate [69815-49-2].
Anhydrous 319.27 [51-40-1].
»Norepinephrine Bitartrate contains not less than 97.0percent and not more than 102.0percent of C8H11NO3·C4H6O6,calculated on the anhydrous basis.
Packaging and storage—
Preserve in tight,light-resistant containers.Store at 25
,excursions permitted between 15and 30.
,excursions permitted between 15and 30.
Identification—
A:Infrared Absorption á197Kñ.
B:
To a solution of 10mg in 2mLof water add 1drop of ferric chloride TS:an intensely green color develops.
C:
To 10mLof a solution (1in 10,000)add 1.0mLof 0.10Niodine.Allow to stand for 5minutes,and add 2.0mLof 0.10Nsodium thiosulfate:the solution is colorless or has at most a slight pink or slight violet color (epinephrineand isoproterenolat the same pH,about 3.5,give a strong red-brown or violet color).
Specific rotation á781Sñ:
between -10and -12.
and -12.
Test solution:
50mg per mL,in water.
Water,Method Iá921ñ:
between 4.5%and 5.8%.
Residue on ignition á281ñ:
negligible,from 200mg.
Limit of arterenone—
Its absorptivity (see Spectrophotometry and Light-scattering á851ñ)at 310nm,determined in a solution containing 2mg per mL,is not more than 0.2.
Assay—
Dissolve about 500mg of Norepinephrine Bitartrate,accurately weighed,in 20mLof glacial acetic acid,warming slightly if necessary to effect solution.Add 2drops of crystal violet TS,and titrate with 0.1Nperchloric acid VS.Perform a blank determination,and make any necessary correction.Each mLof 0.1Nperchloric acid is equivalent to 31.93mg of C8H11NO3·C4H6O6.
Auxiliary Information—
Staff Liaison:Andrzej Wilk,Ph.D.,Senior Scientific Associate
Expert Committee:(PA5)Pharmaceutical Analysis 5
USP28–NF23Page 1392
Pharmacopeial Forum:Volume No.29(5)Page 1547
Phone Number:1-301-816-8305