| Trolamine CDMF 500ML | |||
| 93870LM500 | 34588D216DU | ||
| CDMF | 34588D2 | ||
| 102-71-6 | 74465 | ||
| C6H15NO3 | April 2021 | ||
| 149.19 | March 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. (USP-NF/Ph.Eur) |
| 2 | Solubility | Passes | Miscible with water and with alcohol, ethanol (96%), soluble in chloroform., in methylene chloride. (USP-NF/Ph.Eur) |
| 3 | Appearance of solution | Passes | The solution should be clear and not more intensely coloured than reference solution B6. (Ph.Eur) |
| 4 | Identification (By IR) | Complies | IR spectra of the sample should be concomittant with IR spectra of the corresponding standard. (USP-NF) |
| 5 | Identification (By chemical test) | Complies | The blue color should remain unchange. (USP-NF/Ph.Eur) |
| 6 | Identification (By Chemical test) | Complies | A carmine red color is produced. (USP-NF) |
| 7 | Identification (By Refractive index) | 1.483 | 1.482-1.485 (USP-NF/Ph.Eur) |
| 8 | Identification (By Relative density) | 1.125 | 1.120-1.130 (Ph.Eur) |
| 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). (Ph.Eur) |
| 10 | Specific gravity, 25°C | 1.124 | 1.120 - 1.128 (USP-NF) |
| 11 | Assay (Anhydrous basis) | 99.8% | 99.0% - 103.0% m/m (USP-NF/Ph.Eur) |
| 12 | Related substances: Impurity A (Ethanolamine) | 0.028% | 0.1% max. (Ph.Eur) |
| 13 | Related substances: Impurity B (Diethanolamine) | Not detected | 0.5% max. (Ph.Eur) |
| 14 | Related substances: Impurity C (N-nitrosodiethanolamine) | Not detected | 24ppb max. (Ph.Eur) |
| 15 | Related substances: Total impurity | 0.69% | 1.0% max. (Ph.Eur) |
| 16 | Water | 0.11% | NMT 0.5% w/w (USP-NF) |
| 17 | Residue on ignition /Sulfated ash | 0.03% | NMT 0.05% w/w (USP-NF) |
Remarks: THE CAPTIONED MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF USP, CP 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.
