1 | Description | Clear, colorless slightly hygroscopic liquid | Clear, colorless slightly hydroscopic liquid |
2 | Appearance | Complies | The substance to be examined is clear and not more intensely coloured than reference solution Y7. |
3 | Miscibility | Complies | Miscible with water and ethanol (96%). |
4 | Identification by IR | Complies | IR spectra of the sample should be concomitant with IR spectra of the standard |
5 | Identification by Chemical test | Complies | A reddish-brown color develops, reaching a maximum intensity after about 5 minutes. |
6 | Boiling range (95%) | 165.0°C - 167.0°C | 164.5°C to 167.5°C |
7 | Relative density, 20°C | 0.942 | 0.941 to 0.944 |
8 | Refractive index (20°C ± 0.5°C) | 1.437 | 1.437 to 1.438 |
9 | Acidity | Complies | NMT 5.0ml of 0.02M potassium hydroxide is required to restore the intial bluish-green color |
10 | Alkalinity | Complies | NMT 0.5ml of 0.02M hydrochloric acid is required to restore the intial yellow color |
11 | Non-volatile matter | 8ppm | NMT 20ppm |
12 | Chloride (Cl) | Less than 10ppm | NMT 10ppm |
13 | Sulphate (SO4) | Less than 10ppm | NMT 10ppm |
14 | Related substances (Any impurity) | 0.01% | NMT 0.1% |
15 | Related substances (Total impurity) | 0.02% | NMT 0.3% |
16 | UV absorbance profile (10mm cell)@270nm | 0.544 | NMT 1.0 |
17 | UV absorbance profile (10mm cell)@300nm | 0.067 | NMT 0.1 |
18 | UV absorbance profile (10mm cell)@360nm | 0.000 | NMT 0.01 |
19 | Purity (By GC) | 99.98% | NLT 99.8% |
20 | Water (By KF) | 0.033% | NMT 0.1% (w/w) |
21 | Bacterial endotoxins | Less than 2.0 EU/ml | NMT 2.0 EU/ml |
22 | Total aerobic bacterial count | Less than 100CFU/ml | NMT 100CFU/ml |
23 | Total combined yeast and molds count | Less than 10CFU/ml | NMT 10CFU/ml |
24 | E.coli | Absent/ml | Should be absent/ml |
25 | Salmonella | Absent/ 10ml | Should be absent/ 10ml |
26 | Pseud. aeruginosa | Absent/ml | Should be absent/ml |
27 | Staphylococcus aureus | Absent/ml | Should be absent/ml |
28 | Bile-tolerant gram negative bacteria | Absent/ml | Should be absent/ml |