Trolamine USP-NF/Ph.Eur PARENTEX 25LT Go Back


: 102-71-6

Molecular Formula

: C6H15NO3

Molecular Weight

: 149.19
Appearance/Description: Clear, Colorless to slightly pale yellow, viscous, very hygroscopic liquid having a slight ammoniacal odor.
Solubility: Miscible with water and with alcohol, ethanol (96%), soluble in chloroform., in methylene chloride
Appearance of solution: The solution is clear and not more intensely coloured than reference solution B6.
Identification (By IR): IR spectra of the sample should be concomittant with IR spectra of the corresponding standard.
Identification (By chemical test): The blue color should remain unchange.
Identification (By Chemical test): A carmine red color is produced.
Identification (By Refractive index): 1.482-1.485
Identification (By Relative density): 1.120-1.130
Identification (By Chromatography): The principal peak in the chromatogram obtained with the test solution is similar in retention time and size to the principal peak in the chromatogram obtained with reference solution (a).
Specific gravity, 25°C: 1.120 - 1.128
Assay (Anhydrous basis): 99.0% - 103.0% m/m
Assay (Anhydrous basis): 99.0% -107.4% m/m
Related substances: Impurity A (Ethanolamine): NMT 0.1%
Related substances: Impurity B (Diethanolamine): NMT 0.5%
Related substances: Impurity C (N-nitrosodiethanolamine): NMT 24ppb
Related substances: Total impurity: NMT 1.0%
Water: NMT 0.5% w/w
Residue on ignition /Sulfated ash: NMT 0.05% w/w
Total aerobic microbial count: NMT 100 CFU/ml
Total combined yeast and molds count: NMT 10 CFU/ml
Bacterial endotoxins: NMT 0.5 EU/mg
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