Tromethamine
;)
1,3-Propanediol,2-amino-2-(hydroxymethyl)-.
2-Amino-2-(hydroxymethyl)-1,3-propanediol [77-86-1].
»Tromethamine contains not less than 99.0percent and not more than 101.0percent of C4H11NO3,calculated on the dried basis.
Packaging and storage—
Preserve in tight containers.
Identification—
A:
Infrared Absorption á197Mñ.
B:
To 4.5mLof a saturated solution of salicylaldehyde add 0.5mLof glacial acetic acid,and mix.Add 4.0mLof a solution of Tromethamine (1in 5),and mix:a yellow color is produced.
C:
To 0.5mLof a 4in 10solution of ceric ammonium nitrate in 2Nnitric acid add 3mLof water and 0.5mLof a solution of Tromethamine (1in 5),and mix:the color changes from light yellow to orange.
pHá791ñ:
between 10.0and 11.5,in a solution (1in 20).
Loss on drying á731ñ—
Dry it at 105
for 3hours:it loses not more than 1.0%of its weight.
for 3hours:it loses not more than 1.0%of its weight.
Residue on ignition á281ñ:
not more than 0.1%.
Heavy metals,Method IIá231ñ:
0.001%.
Organic volatile impurities,Method Vá467ñ:
meets the requirements.
Assay—
Dissolve about 250mg of Tromethamine,accurately weighed,in 100mLof water,add bromocresol purple TS,and titrate with 0.1Nhydrochloric acid VSto a yellow endpoint.Each mLof 0.1Nhydrochloric acid is equivalent to 12.11mg of C4H11NO3.
Auxiliary Information—
Staff Liaison:Lawrence Evans,III,Ph.D.,Scientist
Expert Committee:(PA6)Pharmaceutical Analysis 6
USP28–NF23Page 1997
Phone Number:1-301-816-8389