| Triacetin USP/Ph.Eur 2LT | |||
| 97863LC200 | 414437125GW | ||
| USP/Ph.Eur | 4144371 | ||
| 102-76-1 | 96825 | ||
| C9H14O6 | July 2023 | ||
| 218.21 | June 2026 | ||
| Sr.No. | Test | Result | Specification |
|---|---|---|---|
| 1 | Appearance/Description | Clear, colourless, slightly viscous oily liquid, Fatty odour not more intensely coloured than reference solution Y6. | Clear, colourless, slightly viscous oily liquid, Fatty odour not more intensely coloured than reference solution Y6 |
| 2 | Solubility | Complies | Soluble in water, miscible with ethanol (96%), toluene alcohol, ether, and with chloroform |
| 3 | Boiling point | 261°C | About 260°C. |
| 4 | Identification (By IR) | Complies | IR spectra of the sample should be concomitant with IR spectra of the corresponding standard. |
| 5 | Identification (By GC) | Complies | The retention time of the triacetin peak of the sample solution corresponds to that of the standard, as obtained in the assay. |
| 6 | Acidity | Complies | The pink color of the mixture should persist for 15 S |
| 7 | Relative density, 20°C | 1.160 | 1.159-1.164 |
| 8 | Refractive index (20°C ± 0.5°C) | 1.431 | 1.429-1.432 |
| 9 | Assay (On anhydrous basis , by GC) | 99.8% | NLT 97.0% and NMT 102.0% |
| 10 | Organic impurities: Acetic acid | Not detected | NMT 0.1% |
| 11 | Organic impurities: Glycerol | Not detected | NMT 0.1% |
| 12 | Organic impurities: 1-Monoacetin | 0.004% | NMT 0.1% |
| 13 | Organic impurities: 2-Monoacetin | Not detected | NMT 0.1% |
| 14 | Organic impurities: 1,3-Diacetin | 0.02% | NMT 0.1% |
| 15 | Organic impurities: 1,2-Diacetin | Not detected | NMT 0.1% |
| 16 | Organic impurities: Individual, unspecified impurity | 0.02% | NMT 0.1% |
| 17 | Organic impurities; Total impurities | 0.14% | NMT 0.2% |
| 18 | Water | 0.02% | NMT 0.2% |
| 19 | Assay (By Titration) | 99.21% | 97.0% - 100.5% |
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.
