1 | Description | Clear colourless liquid with a characteristic odour. | Clear colourless liquid with a chracteristic odour |
2 | Appearance | Passes | The substance to be examined is clear and not more intensely coloured than reference solution Y7. |
3 | Miscibility | Passes | Miscible with ethanol (95%), water & most common solvent |
4 | Identification by IR | Complies | Conforms to the structure |
5 | Identification by Chemical test | Passes | To pass the test |
6 | Boiling range (95%) | 165.0°C to 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) | 1.438 | 1.437 to 1.438 |
9 | Acidity | Complies | To comply the test |
10 | Alkalinity | Complies | To comply the test |
11 | Non-volatile matter | 12ppm | Not more than 20ppm |
12 | Chloride (Cl) | Less than 10ppm | Not more than 10ppm |
13 | Sulphate (SO4) | Less than 10ppm | Not more than 10ppm |
14 | Lead (Pb) | 0.03ppm | Not more than 0.5ppm |
15 | Iron (Fe) | 0.08ppm | Not more than 1ppm |
16 | Copper (Cu) | 0.01ppm | Not more than 1ppm |
17 | Arsenic (As) | 0.74ppm | Not more than 1.5ppm |
18 | Cadmium(Cd) | 0.03ppm | Not more than 0.2ppm |
19 | Mercury(Hg) | 0.23ppm | Not more than 0.3ppm |
20 | Heavy metals (as Pb) | 0.03ppm | 10ppm max |
21 | Related substances (Any impurity) | 0.04% | Not more than 0.1% |
22 | Related substances (Total impurity) | 0.07% | Not more than 0.3% |
23 | UV absorbance profile (10mm cell)@270nm | 0.447 | 1.0 max |
24 | UV absorbance profile (10mm cell)@300nm | 0.042 | 0.1 max |
25 | UV absorbance profile (10mm cell)@360nm | 0.001 | 0.01 max |
26 | Purity (By GC) | 99.93% | Min.99.8% |
27 | Water (By KF) | 0.033% | Not more than 0.05% (w/w) |
28 | Bacterial endotoxins | Less than 2.0 EU/ml | NMT 2.0 EU/ml |
29 | Total aerobic bacterial count | Less than 100CFU/ml | NMT 100CFU/ml |
30 | Total combined yeast and molds count | Less than 10CFU/ml | NMT 10CFU/ml |
31 | E.coli | Absent/ml | Must be Absent per ml |
32 | Salmonella | Absent/10 ml | Must be Absent per 10 ml |
33 | Pseud. aeruginosa | Absent/ml | Must be Absent per ml |
34 | Staphylococcus aureus | Absent/ml | Must be Absent per ml |
35 | Bile-tolerant gram negative bacteria | Absent/ml | Must be Absent per ml |