1 | Description | Clear colorless liquid with a characteristic odour | Clear colourless liquid with a chracteristic odour |
2 | Appearance | Complies | 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 - 167.5°C | 164.5°C to 167.5°C |
7 | Relative density, 20°C | 0.941 | 0.941-0.944 |
8 | Refractive index, 20°C ± 0.5°C | 1.437 | 1.437-1.438 |
9 | Acidity | Complies | To comply the test |
10 | Alkalinity | Nil | To comply the test |
11 | Non-volatile matter | 8ppm | Not more than 20ppm |
12 | Chloride (Cl) | NMT 10ppm | Not more than 10ppm |
13 | Sulphate (SO4) | NMT 10ppm | Not more than 10ppm |
14 | Lead (Pb) | Not detected | Not more than 0.5ppm |
15 | Iron (Fe) | Not detected | Not more than 1ppm |
16 | Copper (Cu) | Not detected | Not more than 1ppm |
17 | Arsenic (As) | Not detected | Not more than 1.5ppm |
18 | Cadmium(Cd) | Not detected | Not more than 0.2ppm |
19 | Mercury(Hg) | Not detected | Not more than 0.3ppm |
20 | Heavy metals | NMT 10ppm | 10ppm max |
21 | Related substances (Any impurity) | NMT 0.1% | Not more than 0.1% |
22 | Related substances (Total impurity) | NMT 0.3% | Not more than 0.3% |
23 | UV absorbance profile (10mm cell) at 270 nm | 0.609 | 1.0 max. |
24 | UV absorbance profile (10mm cell) at 300 nm | 0.086 | 0.1 max. |
25 | UV absorbance profile (10mm cell) at 360nm | 0.006 | 0.01 max. |
26 | Purity (By GC) | 99.92% | Min.99.8% |
27 | Water (By KF) | 0.048% | Not more than 0.05% (w/w) |
28 | Bacterial endotoxins | Complies | NMT 2.0 EU/ml |
29 | Total aerobic bacterial count | Absent/ml | NMT 100CFU/ml |
30 | Total combined yeast and molds count | Absent/ml | NMT 10CFU/ml |
31 | E.coli | Absent/ml | Must be Absent per ml |
32 | Salmonella | Absent/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 |