| Dimethyl sulphoxide CDMF PARENTEX 2L | |||
| P3620LC200 | 48131C307BZ | ||
| CDMF PARENTEX | 48131C3 | ||
| 67-68-5 | 118416 | ||
| C2H6OS | February 2026 | ||
| 78.13 | January 2029 | ||
| Sr.No. | Test | Result | Specification | Method Reference |
|---|---|---|---|---|
| 1 | Appearance/Description | A colorless liquid. | A colorless liquid | CP |
| 2 | Solubility | Complies | Miscible with water, ethanol and ether, insoluble in alkane | CP |
| 3 | Identification (By IR) | Complies | IR spectra of the sample should be concomitant with IR spectra of standard | USP/Ph.Eur/CP |
| 4 | Identification (By chemical test 1) | Complies | A deep violet, crystalline solid should obtain which should be 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/CP |
| 6 | Specific gravity, 25°C | 1.098 | Between 1.095 to 1.101 | USP |
| 7 | Relative density, 20°C | 1.101 | 1.100 - 1.104 | Ph. Eur |
| 8 | Refractive index (20°C ± 0.5°C) | 1.479 | 1.478 - 1.480 | Ph. Eur/CP |
| 9 | Refractive index, 25°C | 1.4763 | 1.4755 - 1.4775 | USP |
| 10 | Freezing point | 18.5°C | NLT 18.3°C | Ph.Eur |
| 11 | Acidity | 1.0 ml of 0.01N sodium hydroxide consume | Not more than 5.0 ml of 0.01N sodium hydroxide should consume | USP/ Ph.Eur/CP |
| 12 | Water (By KF) | 0.067% | NMT 0.1% | USP |
| 13 | UV absorbance profile (10mm cell)@270nm-350nm | Complies | The spectrum is smooth with no absorption maxima | USP/ Ph.Eur/CP |
| 14 | UV absorbance ratio (A285nm/A275nm) | 0.35 | NMT 0.65 | USP/CP |
| 15 | UV absorbance ratio (A295nm/A275nm) | 0.22 | NMT 0.45 | USP/CP |
| 16 | UV absorbance profile (10mm cell)@275nm | 0.085 | NMT 0.20 | USP |
| 17 | UV absorbance profile (10mm cell)@285nm | 0.030 | NMT 0.20 | Ph.Eur/CP |
| 18 | UV absorbance profile (10mm cell)@295nm | 0.019 | NMT 0.20 | Ph.Eur/CP |
| 19 | Substance darkened by potassium hydroxide | 0.007 | The absorbance of the solution at 350nm, not more than 0.023 | CP |
| 20 | Limit of Non-volatile residue | 0.007% | NMT 0.01% | CP |
| 21 | Related compounds / Related substances – Dimethyl sulfone | Not detected | NMT 0.10% | CP |
| 22 | Related compunds / Related substances - Total impurities | 0.005% | NMT 0.1% | CP |
| 23 | Assay (Anhydrous basis) | 100.05% | NLT 99.9% | USP/CP |
| 24 | Total aerobic microbial count | Less than 1000 CFU/ml | NMT 1000 CFU/ml | In-house |
| 25 | Total combined yeast and mould count | Less than 100 CFU/ml | NMT 100 CFU/ml | In-house |
| 26 | Bacterial endotoxin | Less than 2.5 EU/ml | NMT 2.5 EU/ml | In-house |
Remarks: THE CAPTIONED BATCH MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF THE ABOVE 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.
