Tromethamine Click to View Image C4H11NO3 121.14
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. USP Reference standards á11ñ USP Tromethamine RS. 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. Melting range á741ñ: between 168and 172. pHá791ñ: between 10.0and 11.5,in a solution (1in 20). Loss on drying á731ñ Dry it at 105for 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