(met'' a ram' i nol bye tar' trate).
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.
USP Reference standards 11
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%.
Heavy metals, Method I 231: 0.002%.
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.
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USP35NF30 Page 3828Pharmacopeial Forum: Volume No. 29(5) Page 1533