| Dimethyl sulphoxide USP/Ph.Eur PARENTEX 200L- SS Drum | |||
| P0620SL200 | 45382B531AY | ||
| USP/Ph.Eur PARENTEX | 45382B5 | ||
| 67-68-5 | 112428 | ||
| C2H6OS | January 2025 | ||
| 78.13 | December 2027 | ||
| Sr.No. | Test | Result | Specification | Method Reference |
|---|---|---|---|---|
| 1 | Appearance/Description | A clear, colorless, odorless, hygroscopic liquid. | A clear, colorless, odorless, hygroscopic liquid or crystals. | USP / Ph.Eur/In-house |
| 2 | Solubility | Complies | Soluble in water. Miscible with ethanol (96 per cent ). | USP/ Ph.Eur/In-house |
| 3 | Identification (By IR) | Complies | IR spectra of the sample should be concomittant with IR pectra of the corresponding standard | USP / Ph.Eur |
| 4 | Identification (By chemical test 1) | Complies | A deep violet, crystalline solid should obtaine which should soluble in chloroform, yielding a red solution. | USP |
| 5 | Identification (By chemical test 2) | Complies | The colour changes to green or bluish-green. Cool.The colour changes to greenish-yellow. | Ph.Eur |
| 6 | Identification (by Relative density, 20°C) | 1.102 | 1.100-1.104 | Ph.Eur |
| 7 | Identification (By Refractive index, 20±0.5°C) | 1.479 | 1.478-1.480 | Ph.Eur |
| 8 | Specific gravity, 25°C | 1.097 | Between 1.095 to 1.101 | USP |
| 9 | Relative density,20°C | 1.102 | 1.100-1.104 | Ph.Eur |
| 10 | Refractive index (20°C ± 0.5°C) | 1.479 | 1.478-1.480 | Ph.Eur |
| 11 | Refractive index, 25°C | 1.4769 | 1.4755 - 1.4775 | USP |
| 12 | Freezing point | 18.8°C | NLT 18.3°C | Ph.Eur |
| 13 | Acidity | 1.1ml of 0.01N sodium hydroxide consumed | Not more than 5.0ml of 0.01N sodium hydroxide should consume | USP/Ph.Eur |
| 14 | Water | 0.032% | NMT 0.1% | USP/Ph.Eur |
| 15 | UV absorbance profile (10mm cell)@270nm-350nm | Complies | The spectrum is smooth with no absorption maxima. | USP/Ph.Eur |
| 16 | UV absorbance ratio (A285nm/A275nm) | 0.39 | NMT 0.65 | USP |
| 17 | UV absorbance ratio (A295nm/A275nm) | 0.23 | NMT 0.45 | USP |
| 18 | UV absorbance profile (10mm cell)@275nm | 0.096 | NMT 0.20 | USP |
| 19 | UV absorbance profile (10mm cell)@285nm | 0.038 | NMT 0.20 | Ph.Eur |
| 20 | UV absorbance profile (10mm cell)@295nm | 0.023 | NMT 0.20 | Ph.Eur |
| 21 | Limit of Non volatile residue | 0.0012% | NMT 0.01% | USP |
| 22 | Related compunds / Related substances - Total impurities | 0.01% | NMT 0.10% | USP/Ph.Eur |
| 23 | Related substance (Unspecified impurities) | 0.002% | NMT 0.10% | Ph.Eur |
| 24 | Assay (Anhydrous basis) | 99.98% | NLT 99.9% | USP |
| 25 | Total aerobic microbial count | Less than 1000 CFU/mL | NMT 1000 CFU/mL | In-house |
| 26 | Total Yeast and mold count | Less than 100 CFU/mL | NMT 100 CFU/mL | In-house |
Remarks: THE CAPTIONED BATCH MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF THE ABOVE SPECIFICATION AS WELL AS USP, Ph.Eur SPECIFICATION.
Actylis 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.
