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Metaraminol Bitartrate
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C9H13NO2·C4H6O6 317.29

Benzenemethanol, -(1-aminoethyl)-3-hydroxy-, [R-(R*,S*)]-, [R-(R*,R*)]-2,3-dihydroxybutanedioate (1:1) (salt).
()--(1-Aminoethyl)-m-hydroxybenzyl alcohol tartrate (1:1) (salt) [33402-03-8].
» Metaraminol Bitartrate contains not less than 99.0 percent and not more than 100.5 percent of C9H13NO2·C4H6O6, calculated on the dried basis.
Packaging and storage— Preserve in well-closed containers. Store at 25, excursions permitted between 15 and 30.
Identification—
B: To 0.5 mL of a solution (1 in 2000) add 1 mL of Folin-Ciocalteu phenol TS, then add 5 mL of sodium carbonate solution (1 in 10), mix, and allow to stand for 5 minutes: an intense blue color appears (presence of a phenol).
C: To 4 mL of a solution (1 in 2000) add 5 mL of pH 9.6 alkaline borate buffer (see Buffer Solutions in the section Reagents, Indicators, and Solutions), then add about 5 mg of -naphthoquinone-4-sodium sulfonate, mix until dissolved, and allow to stand for 5 minutes. Add 0.2 mL of benzalkonium chloride solution (1 in 100), mix, add 5 mL of toluene, and shake: the toluene layer turns purple immediately (distinction from phenylephrine).
Melting range 741: between 171 and 175.
Specific rotation 781S: between 31.5 and 33.5 (= 405 nm).
Test solution: 100 mg per mL, in 0.5 N hydrochloric acid.
pH 791: between 3.2 and 3.5, in a solution (1 in 20).
Loss on drying 731— Dry it at 105 for 2 hours: it loses not more than 1.0% of its weight.
Residue on ignition 281: not more than 0.1%.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay— Dissolve about 600 mg of Metaraminol Bitartrate, accurately weighed, in 20 mL of glacial acetic acid, warming slightly to effect solution. Cool the solution to room temperature, add 2 drops of crystal violet TS, and titrate with 0.1 N perchloric acid VS to an emerald-green color. Perform a blank determination, and make any necessary correction. Each mL of 0.1 N perchloric acid is equivalent to 31.73 mg of C9H13NO2·C4H6O6.
Auxiliary Information— Staff Liaison : Andrzej Wilk, Ph.D., Senior Scientific Associate
Expert Committee : (MDCV05) Monograph Development-Cardiovascular
USP29–NF24 Page 1363
Pharmacopeial Forum : Volume No. 29(5) Page 1533
Phone Number : 1-301-816-8305