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 | IR spectra of the sample should be concomittant with IR spectra of the corresponding standard. |
5 | Identification by Chemical test | Complies | A reddish-brown colour develop, reaching a maximum intensity after about 5 min |
6 | Boiling range (95%) | 164.5°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) | 1.437 | 1.437 - 1.438 |
9 | Acidity | 2.3 mL of 0.02M potassium hydroxide | Not more than 5.0 mL of 0.02M potassium hyrodxide should require to restore the initia (Bluish-green) colour |
10 | Alkalinity | 0.3 mL of 0.02M hydrochloric acid | Not more than 0.5 mL of 0.02M hydrochloric acid should require to restore the initial (Yellow) colour |
11 | Non-volatile matter | 9ppm | 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) | 0.01ppm | Not more than 0.5ppm |
15 | Arsenic (As) | 0.14ppm | Not more than 1.5ppm |
16 | Cadmium(Cd) | 0.01ppm | Not more than 0.2ppm |
17 | Mercury(Hg) | 0.14ppm | Not more than 0.3ppm |
18 | Related substances (Any impurity) | 0.04% | Not more than 0.1% |
19 | Related substances (Total impurity) | 0.08% | Not more than 0.3% |
20 | UV absorbance profile (10mm cell)@270nm | 0.880 | 1.0 max |
21 | UV absorbance profile (10mm cell)@300nm | 0.064 | 0.1 max |
22 | UV absorbance profile (10mm cell)@360nm | 0.002 | 0.01 max |
23 | Purity (By GC) | 99.92% | Min.99.8% |
24 | Water (By KF) | 0.04% | Not more than 0.05% (w/w) |
25 | Bacterial endotoxins | Less than 2.0 EU/mL | NMT 2.0 EU/mL |
26 | Total aerobic bacterial count | Less than 100CFU/mL | NMT 100CFU/mL |
27 | Total combined yeast and molds count | Less than 10CFU/mL | NMT 10CFU/mL |
28 | E.coli | Absent/mL | Must be Absent per mL |
29 | Salmonella | Absent/10 ml | Must be Absent per 10 mL |
30 | Pseud. aeruginosa | Absent/mL | Must be Absent per mL |
31 | Staphylococcus aureus | Absent/mL | Must be Absent per mL |
32 | Bile-tolerant gram negative bacteria | Absent/mL | Must be Absent per mL |