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%) | 164.5°C to 167.5°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 | 6ppm | 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) | B.L.Q.(Q.L.=0.005) | Not more than 0.5ppm |
15 | Iron (Fe) | B.L.Q.(Q.L.=0.005) | Not more than 1ppm |
16 | Copper (Cu) | Less than 1ppm | Not more than 1ppm |
17 | Arsenic (As) | B,L,Q.(Q.L.=0.005) | Not more than 1.5ppm |
18 | Cadmium(Cd) | B.L.Q.(Q.L.=0.005) | Not more than 0.2ppm |
19 | Mercury(Hg) | B.L.Q.(Q.L.=0.005) | Not more than 0.3ppm |
20 | Heavy metals (as Pb) | Less than 10ppm | 10ppm max |
21 | Related substances (Any impurity) | 0.03% | Not more than 0.1% |
22 | Related substances (Total impurity) | 0.06% | Not more than 0.3% |
23 | UV absorbance profile (10mm cell)@270nm | 0.627 | 1.0 max |
24 | UV absorbance profile (10mm cell)@300nm | 0.050 | 0.1 max |
25 | UV absorbance profile (10mm cell)@360nm | 0.000 | 0.01 max |
26 | Purity (By GC) | 99.94% | Min.99.8% |
27 | Water (By KF) | 0.034% | Not more than 0.05% (w/w) |
28 | Bacterial endotoxins | Complies | NMT 2.0 EU/ml |
29 | Total aerobic bacterial count | Absent | NMT 100CFU/ml |
30 | Total combined yeast and molds count | Absent | NMT 10CFU/ml |
31 | E.coli | Absent | Must be Absent per ml |
32 | Salmonella | Absent | Must be Absent per 10 ml |
33 | Pseud. aeruginosa | Absent | Must be Absent per ml |
34 | Staphylococcus aureus | Absent | Must be Absent per ml |
35 | Bile-tolerant gram negative bacteria | Absent | Must be Absent per ml |