Metaraminol Bitartrate
;)
Benzenemethanol,a-(1-aminoethyl)-3-hydroxy-,[R-(R*,S*)]-,[R-(R*,R*)]-2,3-dihydroxybutanedioate (1:1)(salt).
(-)-a-(1-Aminoethyl)-m-hydroxybenzyl alcohol tartrate (1:1)(salt) [33402-03-8].
»Metaraminol Bitartrate contains not less than 99.0percent and not more than 100.5percent of C9H13NO2·C4H6O6,calculated on the dried basis.
Packaging and storage—
Preserve in well-closed containers.Store at 25
,excursions permitted between 15and 30.
,excursions permitted between 15and 30.
Identification—
B:
To 0.5mLof a solution (1in 2000)add 1mLof Folin-Ciocalteu phenol TS,then add 5mLof sodium carbonate solution (1in 10),mix,and allow to stand for 5minutes:an intense blue color appears(presence of a phenol).
C:
To 4mLof a solution (1in 2000)add 5mLof pH9.6alkaline borate buffer (see Buffer Solutionsin the section Reagents,Indicators,and Solutions),then add about 5mg of b-naphthoquinone-4-sodium sulfonate,mix until dissolved,and allow to stand for 5minutes.Add 0.2mLof benzalkonium chloride solution (1in 100),mix,add 5mLof toluene,and shake:the toluene layer turns purple immediately(distinction from phenylephrine).
Specific rotation á781Sñ:
between -31.5and -33.5(l=405nm).
and -33.5(l=405nm).
Test solution:
100mg per mL,in 0.5Nhydrochloric acid.
pHá791ñ:
between 3.2and 3.5,in a solution (1in 20).
Loss on drying á731ñ—
Dry it at 105for 2hours:it loses not more than 1.0%of its weight.
for 2hours:it loses not more than 1.0%of its weight.
Residue on ignition á281ñ:
not more than 0.1%.
Heavy metals,Method Iá231ñ:
0.002%.
Assay—
Dissolve about 600mg of Metaraminol Bitartrate,accurately weighed,in 20mLof glacial acetic acid,warming slightly to effect solution.Cool the solution to room temperature,add 2drops of crystal violet TS,and titrate with 0.1Nperchloric acid VSto an emerald-green color.Perform a blank determination,and make any necessary correction.Each mLof 0.1Nperchloric acid is equivalent to 31.73mg of C9H13NO2·C4H6O6.
Auxiliary Information—
Staff Liaison:Andrzej Wilk,Ph.D.,Senior Scientific Associate
Expert Committee:(PA5)Pharmaceutical Analysis 5
USP28–NF23Page 1230
Pharmacopeial Forum:Volume No.29(5)Page 1533
Phone Number:1-301-816-8305