Print Certificate
Certificate
Trolamine USP-NF/Ph.Eur PARENTEX 2.5LT
P1870LC25036857G126AV
USP-NF/Ph.Eur PARENTEX36857G1
102-71-683707
C6H15NO3January 2022
149.19December 2024
Sr.No.TestResultSpecification
1Appearance/DescriptionClear, Colorless to slightly 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 is 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)1.4831.482-1.485
8Identification (By Relative density)1.1241.120-1.130
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°C1.1231.120 - 1.128
11Assay (Anhydrous basis)99.8%99.0% - 103.0% m/m
12Related substances: Impurity A (Ethanolamine)Not detectedNMT 0.1%
13Related substances: Impurity B (Diethanolamine)0.1%NMT 0.5%
14Related substances: Impurity C (N-nitrosodiethanolamine)Not detectedNMT 24ppb
15Related substances: Total impurity0.3%NMT 1.0%
16Water0.02%NMT 0.5% w/w
17Residue on ignition /Sulfated ash0.03%NMT 0.05% w/w
18Total aerobic microbial countLess than 100 CFU/mlNMT 100 CFU/ml
19Total combined yeast and molds countLess than 10 CFU/mlNMT 10 CFU/ml
20Bacterial endotoxinsLess than 0.5 EU/mgNMT 0.5 EU/mg
Remarks: THE CAPTIONED BATCH MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF THE ABOVE SPECIFICATION AS WELL AS USP-NF, 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.
Print Certificate