| Glycerin IP/BP PARENTEX 2LT | |||
| P2720LC200 | 41013B904FW | ||
| IP/BP PARENTEX | 41013B9 | ||
| 56-81-5 | 97092 | ||
| (CH2OH)2CHOH | June 2023 | ||
| 92.09 | May 2026 | ||
| 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 | Complies | Miscible with water and ethanol(95%), slightly soluble in acetone, practically insoluble in ether,fatty oils, in essential oils and volatile oil. |
| 3 | Identification (By IR) | Complies | IR spectra of the sample solution should be concomitant with the reference spectrum of glycerin (85%) |
| 4 | Identification (By Refractive index, 20±0.5°C) | 1.473 | 1.470 - 1.475 |
| 5 | Identification (By Relative density) | 1.260 | 1.258-1.268 |
| 6 | Appearance of solution | Complies | Solution should be clear and colourless. |
| 7 | Acidity or Alkalinity | Complies | Not more than 0.2ml of 0.1M sodium hydroxide should require to change the colour of the indicator to pink. |
| 8 | Refractive index,20° C | 1.473 | 1.470 - 1.475 |
| 9 | Aldehydes | Complies | Any colour produce should not be more intense than that obtained in a standard preparation (NMT 10ppm) |
| 10 | Ester | Complies | NLT 8.0 ml of 0.1M hydrochloric acid should require to the change the colour of the indicator. |
| 11 | Related substances (Diethylene glycol) | Not detected | NMT 0.1% |
| 12 | Related substances (ethylene glycol) | Not detected | NMT 0.1% |
| 13 | Related substances (Any impurity) | 0.02% | NMT 0.1% |
| 14 | Related substances (Total impurity) | Not detected | NMT 1.0% |
| 15 | Related substances (Any impurity with a retention time less than the retention time of glycerol ) | 0.02% | NMT 0.1% |
| 16 | Related substances: Total of all impurities with retention times greater than the retention time of glycerol | 0.04% | NMT 0.5% |
| 17 | Halogenated compounds | Less than 35ppm | NMT 35ppm |
| 18 | Sugars | Complies | The solution should remain blue and no precipitate should produce |
| 19 | Chlorides | Less than 10ppm | NMT 10ppm |
| 20 | Heavy metals | Less than 5ppm | NMT 5ppm |
| 21 | Water | 0.11% | NMT 2.0% |
| 22 | Sulfated ash | 0.006% | NMT 0.01% |
| 23 | Assay (on Anhydrous basis) | 99.8% | 98.0% - 101.0% |
| 24 | Bacterial endotoxin test | Less than 5.0 EU/gm | NMT 5.0 EU/gm |
| 25 | Total aerobic microbial count | Less than 100 CFU/gm | NMT 100 CFU/gm |
| 26 | Total combined yeast and molds count | Less than 10 CFU/gm | NMT 10 CFU/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.
