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 | Complies | 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 | 1.4756 | 1.4755 - 1.4775 |
12 | Freezing point | 18.4°C | NLT 18.3°C |
13 | Acidity | Complies | Not more than 5.0ml of 0.01N sodium hydroxide should consume |
14 | Water | 0.036% | NMT 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) | 0.34 | NMT 0.65 |
17 | UV absorbance ratio (A295nm/A275nm) | 0.18 | NMT 0.45 |
18 | UV absorbance profile (10mm cell)@275nm | 0.082 | NMT 0.20 |
19 | UV absorbance profile (10mm cell)@285nm | 0.028 | NMT 0.20 |
20 | UV absorbance profile (10mm cell)@295nm | 0.015 | NMT 0.20 |
21 | Limit of Non volatile residue | 0.0005% | NMT 0.01% |
22 | Related compunds / Related substances - Total impurities | 0.04% | NMT 0.10% |
23 | Related substance (Unspecified impurities) | 0.02% | NMT 0.10% |
24 | Assay (Anhydrous basis) | 99.96% | NLT 99.9% |
25 | Total aerobic microbial count | Less than 1000 CFU/mL | NMT 1000 CFU/mL |
26 | Total Yeast and mold count | Less than 100 CFU/mL | NMT 100 CFU/mL |