Diethanolamine
Click to View Image
C4H11NO2 105.14

Ethanol,2,2¢-iminobis-.
2,2¢-Iminodiethanol [111-42-2].
»Diethanolamine is a mixture of ethanolamines,consisting largely of diethanolamine.It contains not less than 98.5percent and not more than 101.0percent of ethanolamines,calculated on the anhydrous basis as NH(C2H4OH)2.
Packaging and storage— Preserve in tight,light-resistant containers.
Identification— The IRabsorption spectrum,between 6.6µm and 12.5µm,of a thin film of it exhibits maxima at about 6.8µm,7.3µm,8.1µm,8.3µm,8.9µm,9.4µm,10.6µm,and 11.6µm.
Refractive index á831ñ: between 1.473and 1.476,at 30.
Water,Method Iá921ñ: not more than 0.15%,a 20-g test specimen being used,and a mixture of 25mLof glacial acetic acid and 40mLof methanol being used as the solvent.
Limit of triethanolamine—
Mixed indicator— Dissolve 0.15g of methyl orange and 0.08g of xylene cyanole FFin 100mLof water,and mix.
Procedure— Place 100mLof methanol and 6to 8drops of Mixed indicatorin a 500-mLglass-stoppered conical flask,and neutralize with 0.1Nalcoholic sulfuric acid or 0.1Nalcoholic potassium hydroxide.The neutral solution is amber when viewed by transmitted light and is red-brown when viewed by reflected light.Add about 20g of test specimen,accurately weighed.Cautiously add 75mLof acetic anhydride,and swirl to effect complete solution.Allow to stand at room temperature for 30minutes.Cool to room temperature,if necessary.Titrate with 0.5Nalcoholic sulfuric acid VS.Perform a blank determination,and make any necessary correction.Each mLof 0.5Nalcoholic sulfuric acid is equivalent to 74.6mg of triethanolamine:the limit is 1.0%,by weight.
Assay— Transfer about 2g of Diethanolamine,accurately weighed,to a 250-mLconical flask.Add 50mLof water and bromocresol green TS,and titrate with 0.5Nhydrochloric acid VS.Perform a blank determination,and make any necessary correction.Each mLof 0.5Nhydrochloric acid is equivalent to 52.57mg of diethanolamine,expressed as NH(C2H4OH)2.
Auxiliary Information— Staff Liaison:Daniel K.Bempong,Ph.D.,Scientist
Expert Committee:(EMC)Excipients:Monograph Content
USP28–NF23Page 2998
Phone Number:1-301-816-8143