| Glycerin USP/Ph.Eur 25LT | |||
| 97720LL025 | 428947108BX | ||
| USP/Ph.Eur | 4289471 | ||
| 56-81-5 | 101562 | ||
| (CH2OH)2CHOH | February 2024 | ||
| 92.09 | January 2027 | ||
| Sr.No. | Test | Result | Specification |
|---|---|---|---|
| 1 | Appearance/Description | Clear, colorless, syrupy liquid, unctuous to the touch, Its solutions are neutral to litmus. | Clear, colorless, syrupy liquid, unctuous to the touch, Its solutions are neutral to litmus |
| 2 | Solubility | Complies | Miscible with water, ethanol(96%) and with alcohol .slightly soluble in acetone, Insoluble in fatty oils, in essential oils in chloroform, in ether, and in fixed and volatile oils. |
| 3 | Identification (by IR) | Complies | IR spectra of the sample should be concomitant with IR spectra of the corresponding standard |
| 4 | Identification (Diethylene glycol) | Not detected | NMT 0.10% |
| 5 | Identification (Ethylene glycol) | Not detected | NMT 0.10% |
| 6 | Identification (By GC Chromatogram) | Complies | The retention time of the glycerin peak of the sample solution corresponds to that obtained in the standard solution |
| 7 | Identification (By Refractive index, 20±0.5°C) | 1.474 | 1.470 - 1.475 |
| 8 | Identification (By Relative density) | 1.259 | 1.258-1.268 |
| 9 | Appearance of solution | Complies | Clear and colorless solution |
| 10 | Color | Complies | Color of the sample should not be darker than the color of the standard |
| 11 | Acidity or Alkalinity | Complies | Not more than 0.2ml of 0.1M sodium hydroxide is required to change the color of the indicator to pink. |
| 12 | Refractive index,20° C | 1.474 | 1.470 - 1.475 |
| 13 | Specific gravity, 25°C | 1.250 | NLT 1.249 |
| 14 | Aldehydes | Less than 10ppm | NMT 10ppm |
| 15 | Impurity A (Diethylene glycol) | Not detected | NMT 0.1% |
| 16 | Related substances (Any impurity with a retention time less than the retention time of glycerol ) | 0.05% | NMT 0.1% |
| 17 | Related substances: Total of all impurities with retention times greater than the retention time of glycerol | 0.01% | NMT 0.5% |
| 18 | Related compounds : Individual impurity | 0.05% | NMT 0.1% |
| 19 | Related compounds : Total impurities | 0.1% | NMT 1.0% |
| 20 | Halogenated compounds | Less than 35ppm | NMT 35ppm |
| 21 | Sugars | Complies | The solution remains blue and no precipitate should form |
| 22 | Chlorides | Less than 10ppm | NMT 10ppm |
| 23 | Sulphate (SO4) | Less than 20ppm | NMT 20ppm |
| 24 | Water | 0.12% | NMT 2.0% |
| 25 | Sulphated ash / Residue on ignition | 0.005% | NMT 0.01% |
| 26 | Assay (anhydrous substance) | 99.8% | 99.0% - 101.0% |
| 27 | Chlorinated compounds | Less than 30ppm | NMT 30ppm of Cl |
| 28 | Fatty acids and esters | Complies | NMT 1.0ml of 0.5N sodium hydroxide shall consume. |
| 29 | Ester | Complies | Not less than 8.0 ml of 0.1M hydrochloric acid is required to the change the color of the indicator. |
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.
