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 ethanol (96%) and water. |
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%) | 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 | 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 | Lead (Pb) | 0.13ppm | NMT 0.5ppm |
15 | Iron (Fe) | 0.3ppm | NMT 1ppm |
16 | Copper (Cu) | Not detected | NMT 1ppm |
17 | Arsenic (As) | Not detected | NMT 1.5ppm |
18 | Cadmium(Cd) | Not detected | NMT 0.2ppm |
19 | Mercury(Hg) | Not detected | NMT 0.3ppm |
20 | Heavy metals (as Pb) | 0.13ppm | NMT 10ppm |
21 | Related substances (Any impurity) | 0.03% | NMT 0.1% |
22 | Related substances (Total impurity) | 0.04% | NMT 0.3% |
23 | UV absorbance profile (10mm cell)@270nm | 0.620 | NMT 1.0 |
24 | UV absorbance profile (10mm cell)@300nm | 0.030 | NMT 0.1 |
25 | UV absorbance profile (10mm cell)@360nm | 0.001 | NMT 0.01 |
26 | Purity (By GC) | 99.92% | NLT 99.8% |
27 | Water (By KF) | 0.036% | NMT 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 100 CFU/ml | NMT 100CFU/ml |
30 | Total combined yeast and molds count | Less than 10 CFU/ml | NMT 10CFU/ml |
31 | E.coli | Absent/ml | Should be absent/ml |
32 | Salmonella | Absent/10 ml | Should be absent/ 10ml |
33 | Pseud. aeruginosa | Absent/ml | Should be absent/ml |
34 | Staphylococcus aureus | Absent/ml | Should be absent/ml |
35 | Bile-tolerant gram negative bacteria | Absent/ml | Should be absent/ml |