| Dimethyl sulphoxide USP/Ph.Eur PARENTEX 2.5LT | |||
| P0620LC250 | 35905B501JU | ||
| USP/Ph.Eur PARENTEX | 35905B5 | ||
| 67-68-5 | 80610 | ||
| C2H6OS | October 2021 | ||
| 78.13 | September 2024 | ||
| Sr.No. | Test | Result | Specification |
|---|---|---|---|
| 1 | Appearance/Description | A clear, colorless, odorless, hygroscopic liquid. Melts 18.4°C. Boils at 189°C | A clear, colorless, odorless, hygroscopic liquid or crystals. Melts about 18.4°C. Boils at about 189°C. |
| 2 | Solubility | Passes | Soluble in water. Miscible with ethanol ; practically insoluble in acetone ,in benzene, in chloroform and in ether. |
| 3 | Identification (By IR) | Complies | IR spectra of the sample should be concomittant with IR pectra of the corresponding standard |
| 4 | Identification (By chemical test 1) | Complies | A deep violet, crystalline solid should obtaine which should soluble in chloroform, yielding a red solution. |
| 5 | Identification (By chemical test 2) | Complies | The colour changes to green or bluish-green. Cool.The colour changes to greenish-yellow. |
| 6 | Identification (by Relative density, 20°C) | 1.101 | 1.100-1.104 |
| 7 | Identification (By Refractive index, 20±0.5°C) | 1.479 | 1.478-1.480 |
| 8 | Specific gravity, 25°C | 1.096 | Between 1.095 to 1.101 |
| 9 | Relative density,20°C | 1.101 | 1.100-1.104 |
| 10 | Refractive index (20°C ± 0.5°C) | 1.479 | 1.478-1.480 |
| 11 | Refractive index, 25°C | 1.4760 | 1.4755 - 1.4775 |
| 12 | Freezing point | 18.4°C | Min. 18.3°C |
| 13 | Acidity | 2.5ml of 0.01N sodium hydroxide | Not more than 5.0ml of 0.01N sodium hydroxide should consume |
| 14 | Water | 0.03% | Not more than 0.1% |
| 15 | UV absorbance profile (10mm cell)@270nm-350nm | Complies | The spectrum is smooth with no absorption maxima. |
| 16 | UV absorbance ratio (A285nm/A275nm) | 0.43 | Not more than 0.65 |
| 17 | UV absorbance ratio (A295nm/A275nm) | 0.32 | Not more than 0.45 |
| 18 | UV absorbance profile (10mm cell)@275nm | 0.090 | Not more than 0.20 |
| 19 | UV absorbance profile (10mm cell)@285nm | 0.039 | Not more than 0.20 |
| 20 | UV absorbance profile (10mm cell)@295nm | 0.029 | Not more than 0.20 |
| 21 | Limit of Non volatile residue | 0.0005% | Not more than 0.01% |
| 22 | Related compunds / Related substances - Total impurities | 0.06% | 0.10% max. |
| 23 | Assay (Anhydrous basis) | 99.94% | Not less than 99.9% |
| 24 | Total aerobic microbial count | Less than 1000 CFU/mL | NMT 1000 CFU/mL |
| 25 | Total Yeast and mold count | Less than 100 CFU/mL | NMT 100 CFU/mL |
Remarks: THE CAPTIONED BATCH MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF THE ABOVE SPECIFICATION AS WELL AS USP, 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.
