| Glycerin CDMF PARENTEX 2.5LT | |||
| P3720LC250 | 35805C321IU | ||
| CDMF PARENTEX | 35805C3 | ||
| 56-81-5 | 79123 | ||
| C3H8O3 | September 2021 | ||
| 92.10 | August 2024 | ||
| Sr.No. | Test | Result | Specification |
|---|---|---|---|
| 1 | Description | Clear, colourless, syrupy liquid, unctuous to the touch, having a sweet taste. Has not more than a slight characteristic odor, which is neither harsh nor disagreeable. Is hygroscopic. Its solutions are neutral to litmus. | Clear, colourless, syrupy liquid, unctuous to the touch, having a sweet taste. Has not more than a slight characteristic odor, which is neither harsh nor disagreeable. Is hygroscopic. Its solutions are neutral to litmus. (USP/Ph.Eur) |
| 2 | Solubility | Passes | 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. (USP/Ph.Eur) |
| 3 | Identification (By IR) | Complies | IR spectra of the sample should be concomitant with IR spectra of the standard. (USP/Ph.Eur) |
| 4 | Identification (Diethylene glycol) | Not detected | NMT 0.10% (USP) |
| 5 | Identification (Ethylene glycol) | Not detected | NMT 0.10% (USP) |
| 6 | Identification (By GC Chromatogram) | Complies | The retention time of the glycerine peak of the Sample solution corresponds to that obtained in the Standard solution. (USP) |
| 7 | Identification 1 (By Chemical test) | Complies | Within 10 min, the blue colour does not diffuse into the lower layer. (Ph.Eur) |
| 8 | Identification 2 (By Chemical test) | Complies | Vapours (acrolein) are evolved which blacken filter paper impregnated with alkaline potassium tetraiodomercurate solution. (Ph.Eur) |
| 9 | Appearance of solution | Passes | Clear and colorless solution. (Ph.Eur) |
| 10 | Color | Passes | The colour should not be darker than reference solution. (CP) |
| 11 | Acidity or alkalinity | Passes | Pink colour should produce after adding 0.2 mL of 0.1 mol/L sodium hydroxide solution. (CP) |
| 12 | Refractive index, 20°C | 1.473 | 1.470 - 1.475 (Ph.Eur) |
| 13 | Relative density (20°C) | 1.262 | 1.258 - 1.268 (Ph.Eur) |
| 14 | Aldehydes and reducing substances | Passes | The light absorption of the test solution at 655 nm should not be more than that of 2.0 mL of the reference solution. (CP) |
| 15 | Fatty acids and esters | Passes | NMT 2.0 mL of sodium hydroxide (0.1 mol/L) VS should require. (CP) |
| 16 | Related substances: Impurity A (Diethylene glycol) | Not detected | NMT 0.1% (Ph.Eur) |
| 17 | Related substances: Any other impurity with a retention time less than the retention time of glycerol | 0.01% | NMT 0.1% (Ph.Eur) |
| 18 | Related substances: Total of all impurities with retention times greater than the retention time of glycerol | Not detected | NMT 0.5% (Ph.Eur) |
| 19 | Related substances: Individual impurity | 0.01% | NMT 0.1% (USP) |
| 20 | Related substances: Total impurities | 0.02% | NMT 1.0% (USP) |
| 21 | Halogenated compounds | Less than 35 ppm | NMT 35 ppm (Ph.Eur) |
| 22 | Sugars | Passes | The solution should remain blue and no precipitate should form. (CP) |
| 23 | Chlorides | Less than 0.0006% | NMT 0.0006% (CP) |
| 24 | Sulphate | Less than 0.002% | NMT 0.002% (CP) |
| 25 | Water | 0.1% | NMT 2.0% (Ph.Eur) |
| 26 | Residue on ignition | 0.003% | NMT 0.01% (CP) |
| 27 | Assay (Anhydrous basis) | 99.9% | 99.0% - 101.0% (USP) |
| 28 | Chlorinated substances | Less than 0.003% | NMT 0.003% (CP) |
| 29 | Readily carbonizable substances | Passes | Any colour produced should not more intense than that of an equal volume of a reference solution. (CP) |
| 30 | Ammonium | Passes | No odour of ammonia should produced. (CP) |
| 31 | Calcium | Passes | The solution should be clear. (CP) |
| 32 | Iron | Less than 0.00005% | NMT 0.00005% (CP) |
| 33 | Total aerobic microbial count | Less than 100 CFU/g | NMT 100 CFU/g (CP) |
| 34 | Total combined yeast and mold count | Less than 10 CFU/g | NMT 10 CFU/g (CP) |
| 35 | Bacterial endotoxins | Less than 5 EU/g | NMT 5 EU/g (CP) |
| 36 | E.coli | Not detected | Should not be detected. (CP) |
Remarks: THE CAPTIONED BATCH MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF THE ABOVE SPECIFICATION AS WELL AS USP, Ph.Eur AND ChP 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.
