1 | Description | A clear, colorless, odorless, hygroscopic liquid. Melts 18.4°C. Boils at 189°C | A clear, colorless, odorless, hygroscopic liquid. Melts about 18.4°C. Boils at about 189°C. |
2 | Solubility | Passes | Soluble in water; practically insoluble in acetone, in alcohol, in benzene, in chloroform and in ether. |
3 | Identification A (By IR) | Complies | IR spectra of the sample should be concomittant with IR spectra of the corresponding standard |
4 | Identification B (By Chemical test) | Complies | A deep violet, crystalline solid should obtaine which should soluble in chloroform, yielding a red solution. |
5 | Specific gravity (25°C) | 1.097 | Between 1.095 to 1.101 |
6 | Refractive index (25°C) | 1.4760 | Between 1.4755 and 1.4775 |
7 | Acidity | 2.5ml of 0.01N sodium hydroxide | Not more than 5.0ml of 0.01N sodium hydroxide should consume |
8 | Water | 0.06% | Not more than 0.1% |
9 | UV absorbance profile (10mm cell)@275nm | 0.075 | Not more than 0.20 |
10 | UV absorbance profile (10mm cell)@270nm-350nm | Complies | The spectrum is smooth with no absorption maxima. |
11 | UV absorbance ratio (A285nm/A275nm) | 0.28 | Not more than 0.65 |
12 | UV absorbance ratio (A295nm/A275nm) | 0.10 | Not more than 0.45 |
13 | Limit of Non volatile residue | 0.0020% | Not more than 0.01% |
14 | Related compounds : Total impurities | 0.01% | Not more than 0.1% |
15 | Assay (Anhydrous basis) | 99.97% | Not less than 99.9% |
16 | Total aerobic microbial count | Less than 1000 CFU/ml | NMT 1000 CFU/ml |
17 | Total Yeast and mold count | Less than 100 CFU/ml | NMT 100 CFU/ml |