| Assay |
99.0 - 100.5 % |
| Assay (NF) |
98.0 - 100.5 % |
| Purity (GC) |
99.0 - 100.0 % |
| Identity (IR) |
conforms |
| Identification A (Ph Eur) |
conforms |
| Identity B (NF) |
conforms |
| Appearance of solution |
conforms |
| Solubility in ethanol (70%) |
conforms |
| Acidic substances |
conforms |
| Refractive index (n 20/D) |
1.535 - 1.538 |
| Density (d 20 °C/20 °C) |
1.180 - 1.186 |
| Density (d 25 °C/25 °C) |
1.180 - 1.185 |
| Optical rotation (α25/D) |
inactive |
| Dimethyl 4-hydroxyisophthalate (HPLC) |
≤ 0.5 % |
| Salicylic acid (HPLC) |
≤ 0.1 % |
| Methanol (GC) |
≤ 0.10 % |
| Residual solvents (ICH Q3C) |
excluded by manufacturing process |
| 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, NF |
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