| Trolamine USP-NF/Ph.Eur PARENTEX 2.5LT | |||
| P1870LC250 | 36857G126AV | ||
| USP-NF/Ph.Eur PARENTEX | 36857G1 | ||
| 102-71-6 | 90236 | ||
| C6H15NO3 | January 2022 | ||
| 149.19 | December 2024 | ||
| Sr.No. | Test | Result | Specification |
|---|---|---|---|
| 1 | Appearance/Description | Clear, 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. |
| 2 | Solubility | Passes | Miscible with water and with alcohol, ethanol (96%), soluble in chloroform., in methylene chloride |
| 3 | Appearance of solution | Complies | The solution is clear and not more intensely coloured than reference solution B6. |
| 4 | Identification (By IR) | Complies | IR spectra of the sample should be concomittant with IR spectra of the corresponding standard. |
| 5 | Identification (By chemical test) | Complies | The blue color should remain unchange. |
| 6 | Identification (By Chemical test) | Complies | A carmine red color is produced. |
| 7 | Identification (By Refractive index) | 1.483 | 1.482-1.485 |
| 8 | Identification (By Relative density) | 1.124 | 1.120-1.130 |
| 9 | Identification (By Chromatography) | Complies | 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). |
| 10 | Specific gravity, 25°C | 1.123 | 1.120 - 1.128 |
| 11 | Assay (Anhydrous basis) | 99.8% | 99.0% - 103.0% m/m |
| 12 | Assay (anhydrous substance) | 99.8% | 99.0% -107.4% m/m |
| 13 | Related substances: Impurity A (Ethanolamine) | Not detected | NMT 0.1% |
| 14 | Related substances: Impurity B (Diethanolamine) | 0.1% | NMT 0.5% |
| 15 | Related substances: Impurity C (N-nitrosodiethanolamine) | Not detected | NMT 24ppb |
| 16 | Related substances: Total impurity | 0.3% | NMT 1.0% |
| 17 | Water | 0.02% | NMT 0.5% w/w |
| 18 | Residue on ignition /Sulfated ash | 0.03% | NMT 0.05% w/w |
| 19 | Total aerobic microbial count | Less than 100 CFU/ml | NMT 100 CFU/ml |
| 20 | Total combined yeast and molds count | Less than 10 CFU/ml | NMT 10 CFU/ml |
| 21 | Bacterial endotoxins | Less than 0.5 EU/mg | NMT 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.
