| Glycerin USP/Ph.Eur/BP PARENTEX PLUS 2LT | |||
| I0720LC200 | 42651B131LW | ||
| USP/Ph.Eur/BP PARENTEX PLUS | 42651B1 | ||
| 56-81-5 | 100733 | ||
| C3H8O3 | December 2023 | ||
| 92.10 | November 2026 | ||
| 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 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) | 1.260 | 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 0.2 mL of 0.1M sodium hydroxide should require to change the colour of the indicator to pink. |
| 12 | Refractive index,20° C | 1.474 | 1.470 - 1.475 |
| 13 | Specific gravity, 25°C | 1.255 | NLT 1.249 |
| 14 | Aldehydes | Less than 10 ppm | NMT 10 ppm |
| 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 ) | 0.06% | NMT 0.1% |
| 17 | Related substances: Total of all impurities with retention times greater than the retention time of glycerol | Not detected | NMT 0.5% |
| 18 | Related compounds : Individual impurity | 0.08% | NMT 0.1% |
| 19 | Related compounds : Total impurities | 0.1% | 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 10 ppm | NMT 10ppm |
| 23 | Sulphate (SO4) | Less than 20 ppm | NMT 20ppm |
| 24 | Water | 0.1% | NMT 2.0% |
| 25 | Sulphated ash / Residue on ignition | 0.002% | NMT 0.01% |
| 26 | Assay (Anhydrous basis) | 99.8% | 99.0% - 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 |
| 33 | Escherichia coli | Absent/gm | Should be Absent/gm |
| 34 | Salmonella species | Absent/10 gm | Should be Absent/10 gm |
| 35 | Pseudomonas aeruginosa | Absent/gm | Should be Absent/gm |
| 36 | Staphylococcus aureus | Absent/gm | Should be Absent/gm |
Remarks: THE CAPTIONED BATCH MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF THE ABOVE SPECIFICATION AS WELL AS USP, 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.
