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Trolamine USP-NF/ Ph.Eur 25KG
97870LK025369217103BV
USP/Ph.Eur3692171
102-71-682282
C6H15NO3February 2022
149.19January 2025
Sr.No.TestResultSpecification
1Appearance/DescriptionSlightly pale yellow, viscous , very hygroscopic liquid having a slight ammoniacal odor.Clear, Colorless to slightly pale yellow, viscous, very hygroscopic liquid having a slight ammoniacal odor.
2SolubilityPassesMiscible with water and with alcohol, ethanol (96%), soluble in chloroform., in methylene chloride
3Appearance of solutionPassesThe solution should be clear and not more intensely coloured than reference solution B6.
4Identification (By IR)CompliesIR spectra of the sample should be concomittant with IR spectra of the corresponding standard.
5Identification (By chemical test)CompliesThe blue color should remain unchange.
6Identification (By Chemical test)CompliesA carmine red color is produced.
7Identification (By Refractive index)1.4841.482-1.485
8Identification (By Relative density)1.1251.120-1.130
9Identification (By Chromatography)CompliesThe 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).
10Specific gravity, 25°C1.1251.120 - 1.128
11Assay (Anhydrous basis)99.8%99.0% - 103.0% m/m
12Related substances: Impurity A (Ethanolamine)0.01%0.1% max
13Related substances: Impurity B (Diethanolamine)0.04%0.5% max
14Related substances: Impurity C (N-nitrosodiethanolamine)Not detected24ppb max.
15Related substances: Total impurity0.3%1.0% max
16Water0.07%NMT 0.5% w/w
17Residue on ignition /Sulfated ash0.02%NMT 0.05% w/w
Remarks: THE CAPTIONED MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF USP AND PH.EUR SPECIFICATION.
FINAR provides this analytical report in good faith and to the best of its knowledge. It should not be substituted for the users own raw material quality control.
Tested By
(Chemist - Quality Control)
Approved By
(Head - Quality Control)
Computer Generated Report - Does not require Signature.
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