| Glycerin synthetic USP-NF/Ph.Eur/BP PARENTEX 1LT | |||
| P1720LC100 | 40702C226DW | ||
| USP-NF/Ph.Eur/BP PARENTEX | 40702C2 | ||
| 56-81-5 | 99030 | ||
| C3H8O3 | April 2023 | ||
| 92.10 | March 2025 | ||
| Sr.No. | Test | Result | Specification |
|---|---|---|---|
| 1 | Appearance/Description | Clear, colorless, syrupy liquid. | Clear, colorless, syrupy liquid |
| 2 | Solubility | Complies | Miscible with water and methanol |
| 3 | Identification (by IR) | Complies | IR spectra of the sample should be concomitant with IR spectra of the 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) | 1.473 | 1.470 - 1.475 |
| 8 | Identification (by Relative density, 20°C) | 1.264 | 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 | 0.12 mL of 0.1M sodium hydroxide | Not more than 0.2 mL of 0.1M sodium hydroxide should require to change the colour of the indicator to pink. |
| 12 | Refractive index,20° C | 1.473 | 1.470 - 1.475 |
| 13 | Specific gravity, 25°C | 1.260 | NLT 1.249 |
| 14 | Aldehydes | Less than 10 ppm | NMT 10 ppm |
| 15 | Related substances: Impurity A (Diethylene glycol) | Not detected | NMT 0.1% |
| 16 | Related substances: Any other impurity with a retention time less than the retention time of glycerol | 0.01% | NMT 0.1% |
| 17 | Related substances: Total of all impurities with retention times greater than the retention time of glycerol | 0.09% | NMT 0.5% |
| 18 | Related compounds : Individual impurity | 0.03% | NMT 0.1% |
| 19 | Related compounds : Total impurities | 0.08% | NMT 1.0 % |
| 20 | Halogenated compounds | Less than 35 ppm | NMT 35 ppm |
| 21 | Sugars | Complies | The solution should remain blue, no precipitate should form |
| 22 | Chloride (Cl) | Less than 10ppm | NMT 10ppm |
| 23 | Sulphate (SO4) | Less than 20ppm | NMT 20ppm |
| 24 | Water | 0.1% | NMT 2.0% |
| 25 | Sulphated ash / Residue on ignition | 0.004% | NMT 0.01% |
| 26 | Assay (anhydrous substance) | 99.1% | 98.0% - 101.0% |
| 27 | Chlorinated compounds (as Cl) | Less than 30 ppm | NMT 30 ppm of Cl |
| 28 | Fatty acids and esters | Complies | NMT 1.0 mL of 0.5N sodium hydroxide should consume. |
| 29 | Ester | Complies | Not less than 8.0 mL of 0.1M hydrochloric acid is required to the change the colour of the indicator. |
| 30 | Bacterial endotoxins | Less than 5.0 EU/gm | NMT 5.0 EU/gm |
| 31 | Total aerobic microbial count | Less than 100 CFU/gm | NMT 100 CFU/gm |
| 32 | Total Yeast and mold 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 USP-NF, Ph.Eur, 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.
