Norepinephrine Bitartrate
(nor'' ep i nef' rin bye tar' trate).
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C8H11NO3·C4H6O6·H2O 337.28

C8H11NO2·C4H6O6 319.27
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     [51-40-1].
Norepinephrine Bitartrate contains NLT 97.0% and NMT 102.0% of C8H11NO3·C4H6O6, calculated on the anhydrous basis.
•  B. Procedure
Sample solution:  5 mg/mL in water
Analysis:  Add 1 drop of ferric chloride TS.
Acceptance criteria:  An intensely green color develops.
•  C. Procedure
Sample solution:  0.01 µg/mL
Analysis:  Add 1.0 mL of 0.10 N iodine to 10 mL of the Sample solution. Allow to stand for 5 min, and add 2.0 mL of 0.10 N sodium thiosulfate.
Acceptance criteria:  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).
•  Procedure
Sample solution:  25 mg/mL of Norepinephrine Bitartrate in glacial acetic acid. If necessary warm slightly to effect solution.
Analysis:  Add 2 drops of crystal violet TS to the Sample solution, and titrate with 0.1 N perchloric acid VS. Perform a blank determination, and make any necessary correction (see Titrimetry 541). Each mL of 0.1 N perchloric acid is equivalent to 31.93 mg of C8H11NO3·C4H6O6.
Acceptance criteria:  97.0%–102.0% on the anhydrous basis
Inorganic Impurities 
•  Residue on Ignition 281: NMT 0.1%, from 200 mg
Organic Impurities 
•  Procedure: Limit of Arterenone
Sample solution:  2 mg/mL in water
Analysis:  Determine the absorptivity of the Sample solution (see Spectrophotometry and Light-Scattering 851) at 310 nm.
Acceptance criteria:  NMT 0.2
•  Optical Rotation, Specific Rotation 781S: 10 to 12
Sample solution:  50 mg/mL in water
•  Water Determination, Method I 921: 4.5%–5.8%
•  Packaging and Storage: Preserve in tight, light-resistant containers. Store at controlled room temperature.
•  USP Reference Standards 11
USP Norepinephrine Bitartrate RS Click to View Structure
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Sujatha Ramakrishna, Ph.D.
Senior Scientific Liaison
(SM22010) Monographs - Small Molecules 2
Reference Standards RS Technical Services
USP35–NF30 Page 4073
Pharmacopeial Forum: Volume No. 35(5) Page 1165