1 | Appearance/Description | A colorless liquid | A colorless liquid |
2 | Solubility | Complies | Miscible with water, ethanol and ether, insoluble in alkane |
3 | Identification (By IR) | Complies | IR spectra of the sample should be concomitant with IR spectra of standard |
4 | Identification (By chemical test 1) | Complies | A deep violet, crystalline solid should obtain which should be 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 | Specific gravity, 25°C | 1.096 | Between 1.095 to 1.101 |
7 | Relative density, 20°C | 1.101 | 1.100 - 1.104 |
8 | Refractive index (20°C ± 0.5°C) | 1.479 | 1.478 - 1.480 |
9 | Refractive index, 25°C | 1.4765 | 1.4755 - 1.4775 |
10 | Freezing point | 18.4°C | NLT 18.3°C |
11 | Acidity | Complies | Not more than 5.0 ml of 0.01N sodium hydroxide should consume |
12 | Water (By KF) | 0.03% | NMT 0.1% |
13 | UV absorbance profile (10mm cell)@270nm-350nm | Complies | The spectrum is smooth with no absorption maxima |
14 | UV absorbance ratio (A285nm/A275nm) | 0.54 | NMT 0.65 |
15 | UV absorbance ratio (A295nm/A275nm) | 0.30 | NMT 0.45 |
16 | UV absorbance profile (10mm cell)@275nm | 0.183 | NMT 0.20 |
17 | UV absorbance profile (10mm cell)@285nm | 0.100 | NMT 0.20 |
18 | UV absorbance profile (10mm cell)@295nm | 0.056 | NMT 0.20 |
19 | Substance darkened by potassium hydroxide | Complies | The absorbance of the solution at 350nm, not more than 0.023 |
20 | Limit of Non-volatile residue | 0.002% | NMT 0.01% |
21 | Related compounds / Related substances – Dimethyl sulfone | 0.02% | NMT 0.10% |
22 | Related compunds / Related substances - Total impurities | 0.02% | NMT 0.1% |
23 | Assay (Anhydrous basis) | 99.97% | NLT 99.9% |
24 | Total aerobic microbial count | Less than 1000 CFU/ml | NMT 1000 CFU/ml |
25 | Total combined yeast and mould count | Less than 100 CFU/ml | NMT 100 CFU/ml |
26 | Bacterial endotoxin | Less than 2.5 EU/ml | NMT 2.5 EU/ml |