| Propylene glycol USP/Ph.Eur/BP PARENTEX PLUS 2.5LT | |||
| I1400LC250 | 36228B116KU | ||
| USP/Ph.Eur/BP PARENTEX PLUS | 36228B1 | ||
| 57-55-6 | 80308 | ||
| C3H8O2 | November 2021 | ||
| 76.1 | October 2024 | ||
| Sr.No. | Test | Result | Specification |
|---|---|---|---|
| 1 | Description | Clear, colourless, viscous liquid having a slight, characteristic taste. Is practically odourless. Absorbs moisture when exposed to moist air. | Clear, colourless, viscous liquid having a slight, characteristic taste. Is practically odourless. Absorbs moisture when exposed to moist air. |
| 2 | Solubility | Passes | Miscible with water, with ethanol (96%), with acetone, and with chloroform Soluble in ether and will dissolve many essential oils, but is immiscible with fixed 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 propylene glycol peak of the sample solution corresponds to that of the standard solution |
| 7 | Identification (by Relative density, 20°C) | 1.037 | 1.035 - 1.040 |
| 8 | Identification (By Refractive index, 20±0.5°C) | 1.432 | 1.431 - 1.433 |
| 9 | Identification (By Boiling Point) | 187°C | 184° - 189°C |
| 10 | Identification (By Melting point) | 125°C | Crystals should melt between 121 °C to 128 °C. |
| 11 | Specific gravity, 25°C | 1.036 | 1.035 - 1.037 |
| 12 | Relative density, 20°C | 1.037 | 1.035 - 1.040 |
| 13 | Refractive index (20°C ± 0.5°C) | 1.432 | 1.431 - 1.433 |
| 14 | Assay | 99.96% | NLT 99.5% |
| 15 | Residue on ignition | 0.004% | The weight of the residue is NMT 3.5 mg (0.007% max) |
| 16 | Chloride (Cl) | Less than 70ppm | NMT 70ppm |
| 17 | Sulphate (SO4) | Less than 60ppm | NMT 60ppm |
| 18 | Acidity | 0.02 mL of 0.1M sodium hydroxide | Not more than 0.05 mL of 0.1 M sodium hydroxide should require to change the colour of the indicator to blue. |
| 19 | Oxidising substances | Passes | Not more than 0.2 mL of 0.05 M sodium thiosulfate should require. |
| 20 | Reducing substances | Passes | The solution should not change its appearance. |
| 21 | Water | 0.07% | NMT 0.2% |
| 22 | Total aerobic microbial count | Less than 100 CFU/ml | NMT 100 CFU/ml |
| 23 | Total Yeast & mold count | Less than 10 CFU/ml | NMT 10 CFU/ml |
| 24 | Bacterial endotoxins | Less than 0.25 EU/ml | NMT 0.25 EU/ml |
Remarks: THE CAPTIONED BATCH MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF THE ABOVE SPECIFICATION AS WELL AS USP, Ph.Eur AND 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.
