| Glycerol 85% Ph.Eur PARENTEX 25LT | |||
| P6024LL025 | 42792G723AX | ||
| Ph.Eur PARENTEX | 42792G7 | ||
| ---- | 100946 | ||
| January 2024 | |||
| December 2025 | |||
| Sr.No. | Test | Result | Specification |
|---|---|---|---|
| 1 | Appearance | Syrupy liquid, unctuous to the touch, almost colourless, clear, very hygroscopic. | Syrupy liquid, unctuous to the touch, colourless or almost colourless, clear, very hygroscopic. |
| 2 | Solubility | Complies | Miscible with water and with ethanol (96%), slightly soluble in acetone, practically insoluble in fatty oils and in essential oils. |
| 3 | Identification A (By Refractive index, 20±0.5°C) | 1.450 | 1.449 to 1.455 |
| 4 | Identification B (By IR) | Complies | IR spectra of the sample should be concomitant with IR spectra of the corresponding standard. |
| 5 | Identification C (Relative density) | 1.225 | 1.221 to 1.232 |
| 6 | Appearance of solution | Complies | The solution should be clear and colorless. |
| 7 | Acidity or alkalinity | Complies | NMT 0.2ml of 0.1M sodium hydroxide should require to change the color of the indicator to pink. |
| 8 | Refractive index (20°C ± 0.5°C) | 1.450 | 1.449 to 1.455 |
| 9 | Aldehydes | Less than 10ppm | NMT 10ppm |
| 10 | Ester | Complies | NLT 8.0mL of 0.1M hydrochloric acid should require to change the color of the indicator. |
| 11 | Related substances: Impurity A (Diethylene glycol) | Not detected | NMT 0.1% |
| 12 | Related substances: Any other impurity with a retention time less than the retention time of glycerol | 0.01% | NMT 0.1% |
| 13 | Related substances: Total of all impurities with retention times greater than the retention time of glycerol | 0.01% | NMT 0.5% |
| 14 | Halogenated compounds | Less than 30ppm | NMT 30ppm |
| 15 | Sugars | Complies | The solution should remain blue and no precipitate should form. |
| 16 | Chlorides | Less than 10ppm | NMT 10ppm |
| 17 | Water | 14.8% | 12.0% to 16.0% |
| 18 | Sulfated ash | 0.006% | NMT 0.01% |
| 19 | Assay | 85.4% | 83.5% m/m to 88.5% m/m |
| 20 | Total aerobic microbial count | Less than 1000 CFU/gm | NMT 1000 CFU/gm |
| 21 | Total Yeast and mold count | Less than 100 CFU/gm | NMT 100 CFU/gm |
| 22 | Bacterial endotoxins | Less than 5 EU/gm | NMT 5 EU/gm |
Remarks: THE CAPTIONED BATCH MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF THE ABOVE SPECIFICATION AS WELL AS Ph.Eur 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.
