| Assay (GC) |
98.0 - 100.5 % |
| Identity (IR) |
conforms |
| Appearance of solution (nephelometric) |
conforms |
| Clarity of solution |
conforms |
| Colour of solution |
conforms |
| Acidity |
conforms |
| Refractive index (n 20/D) |
1.538 - 1.541 |
| Density (d 20 °C/20 °C) |
1.043 - 1.049 |
| Peroxide value |
≤ 5.0 |
| Related substances (GC) (Benzaldehyde (Impurity A)) |
≤ 0.15 % |
| Related substances (GC) (Cyclohexylmethanol (Impurity B)) |
≤ 0.10 % |
| Related substances (GC) (Sum of peaks with a relative retention less than that of benzyl alcohol) |
≤ 0.04 % |
| Related substances (GC) (Sum of peaks with a relative retention greater than that of benzyl alcohol) |
≤ 0.3 % |
| Related substances (GC) (disregard limit) |
≤ 0.0001 % |
| Benzene (GC) |
≤ 0.0002 % |
| Chlorobenzene (GC) |
≤ 0.01 % |
| Toluene (GC) |
≤ 0.01 % |
| Other residual solvents (ICH Q3C) |
excluded by manufacturing process |
| Evaporation residue |
≤ 0.050 % |
| Water |
≤ 0.10 % |
| Elemental impurity specifications have been set considering ICH Q3D (Guideline for Elemental impurities). Class 1-3 elements are not likely to be present above the ICH Q3D option 1 limit, unless specified and indicated (*). Conforms to Ph Eur, BP, JP, NF |
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