1 | Description | A clear, oily liquid, very slightly yellow. | A clear, oily liquid, colourless or very slightly yellow. (USP-NF/Ph.Eur) |
2 | Solubility | Passes | Practically insoluble in water. Miscible with alcohol, ether and with ethanol (96%). (USP-NF/Ph.Eur) |
3 | Appearance | Passes | Passes test (USP-NF) |
4 | Identification A ( By Relative density, 20°C) | 1.045 | 1.043-1.048 (Ph.Eur) |
5 | Identification B (By Refractive index, 20±0.5°C) | 1.492 | 1.490-1.495 (USP-NF/Ph.Eur) |
6 | Identification C (By IR) | Complies | To comply the test (USP-NF/Ph.Eur) |
7 | Identification D (By TLC) | Complies | The principal spot in the chromatogram obtained with the test solution is similar in position and size to the principal spot in the chromatogram obtained with the reference solution.(PhEur) |
8 | Identification E (By Chemical test) | Complies | To comply the test (Ph.Eur) |
9 | Appearance of Solution | Passes | The substance to be examined is clear and not more intensely coloured than reference solution Y6. (Ph.Eur) |
10 | Specific gravity, 20°C | 1.044 | 1.043-1.048 (USP-NF) |
11 | Refractive index (20°C ± 0.5°C) | 1.492 | 1.490-1.495 (USP-NF) |
12 | Acidity | Passes | Passes test (USP-NF/Ph.Eur) |
13 | Related compounds | 0.5% | 1.0% max (USP-NF/Ph.Eur) |
14 | Water | 0.06% | 0.2% max (USP-NF/Ph.Eur) |
15 | Residue on ignition | 0.05% | NMT 0.1% (USP-NF) |
16 | Assay | 99.8% | 99.0%-101.0% m/m |
17 | Sulphated ash | 0.05% | 0.1% max (Ph.Eur) |