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Norepinephrine Bitartrate
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C8H11NO3·C4H6O6·H2O 337.28

1,2-Benzenediol, 4-(2-amino-1-hydroxyethyl)-, (R)-,[R-(R*,R*)]-2,3-dihydroxybutanedioate (1:1) (salt), monohydrate.
()--(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 97.0 percent and not more than 102.0 percent of C8H11NO3·C4H6O6, calculated on the anhydrous basis.
Packaging and storage— Preserve in tight, light-resistant containers. Store at 25, excursions permitted between 15 and 30.
Identification—
B: To a solution of 10 mg in 2 mL of water add 1 drop of ferric chloride TS: an intensely green color develops.
C: To 10 mL of a solution (1 in 10,000) add 1.0 mL of 0.10 N iodine. Allow to stand for 5 minutes, and add 2.0 mL of 0.10 N sodium thiosulfate: the solution is colorless or has at most a slight pink or slight violet color (epinephrine and isoproterenol at the same pH, about 3.5, give a strong red-brown or violet color).
Specific rotation 781S: between 10 and 12.
Test solution: 50 mg per mL, in water.
Water, Method I 921: between 4.5% and 5.8%.
Residue on ignition 281: negligible, from 200 mg.
Limit of arterenone— Its absorptivity (see Spectrophotometry and Light-scattering 851) at 310 nm, determined in a solution containing 2 mg per mL, is not more than 0.2.
Assay— Dissolve about 500 mg of Norepinephrine Bitartrate, accurately weighed, in 20 mL of glacial acetic acid, warming slightly if necessary to effect solution. Add 2 drops of crystal violet TS, and titrate with 0.1 N perchloric acid VS. Perform a blank determination, and make any necessary correction. Each mL of 0.1 N perchloric acid is equivalent to 31.93 mg of C8H11NO3·C4H6O6.
Auxiliary Information— Staff Liaison : Sujatha Ramakrishna, Ph.D., Scientist
Expert Committee : (MDCV05) Monograph Development-Cardiovascular
USP31–NF26 Page 2824
Pharmacopeial Forum : Volume No. 29(5) Page 1547
Phone Number : 1-301-816-8349