| Glycerin IP/BP PARENTEX 25LT | |||
| P2720LL025 | 36938B904BV | ||
| IP/BP PARENTEX | 36938B9 | ||
| 56-81-5 | 82970 | ||
| (CH2OH)2CHOH | February 2022 | ||
| 92.09 | January 2025 | ||
| Sr.No. | Test | Result | Specification |
|---|---|---|---|
| 1 | Description | Syrupy liquid, unctuous to the touch, colourless, clear, very hygroscopic. | Syrupy liquid, unctuous to the touch, colourless or almost colourless, clear, very hygroscopic. |
| 2 | Solubility | Passes | Miscible with water and ethanol(96%), slightly soluble in acetone, practically insoluble in fatty oils and in essential oils. |
| 3 | Identification (By Refractive index, 20±0.5°C) | 1.473 | 1.470 - 1.475 |
| 4 | Identification (By Relative density) | 1.263 | 1.258-1.268 |
| 5 | Identification (By IR) | Complies | IR spectra of the sample solution should be concomitant with the reference spectrum of glycerin (85%) |
| 6 | Identification (By chemical test 1) | Complies | Within 10 min, the blue colour should not be diffuse into the lower layer |
| 7 | Identification (By chemical test 2) | Complies | Vapours (acrolein) should evolve which blacken filter paper impregnated with alkaline potassium tetraiodomercurate solution(Potassium mercuri-Iodide solution). |
| 8 | Appearance of solution | Passes | Solution should be clear and colourless. |
| 9 | Acidity or Alkalinity | 0.1ml of 0.1M sodium hydroxide | Not more than 0.2ml of 0.1M sodium hydroxide should require to change the colour of the indicator to pink. |
| 10 | Refractive index,20° C | 1.473 | 1.470 - 1.475 |
| 11 | Aldehydes and reducing substances | Passes | Any colour produce should not be more intense than that obtained in a standard preparation (10ppm max) |
| 12 | Ester | Passes | Not less than 8.0 ml of 0.1M hydrochloric acid should require to the change the colour of the indicator. |
| 13 | Related substances (Diethylene glycol) | Not detected | NMT 0.1% |
| 14 | Related substances (Any impurity with a retention time less than the retention time of glycerol ) | 0.003% | NMT 0.1% |
| 15 | Related substances: (Total impurity with retention times greater than the retention time of glycerol) | 0.3% | NMT 0.5% |
| 16 | Ethylene glycol, diethylene glycol and related substances | Not detected | The area of any secondary peak in the chromatogram obtained with the test solution should be less than the area of the peak corresponding to diethylene glycol n the chromatogram obtained with the reference solution. |
| 17 | Halogenated compounds | Less than 35ppm | NMT 35ppm |
| 18 | Sugars | Passes | The solution should remain blue and no precipitate should produce |
| 19 | Chlorides | Less than 10ppm | NMT 10ppm |
| 20 | Sulfate | Less than 30 ppm | NMT 30 ppm |
| 21 | Heavy metals | Less than 5ppm | NMT 5ppm |
| 22 | Iron (Fe) | Less than 4ppm | NMT 4ppm |
| 23 | Water | 0.4% | NMT 2.0% |
| 24 | Sulfated ash | 0.004% | NMT 0.01% |
| 25 | Assay | 99.7% | 98.0% - 101.0% m/m (Anhydrous substance) |
| 26 | Bacterial endotoxin test | Less than 5.0 EU/gm | NMT 5.0 EU/gm |
Remarks: THE CAPTIONED BATCH MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF THE ABOVE SPECIFICATION AS WELL AS IP, BP 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.
