Specifications | |
---|---|
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 |
Heavy metals (as Pb) | ≤ 0.002 % |
Dimethyl 4-hydroxyisophthalate (HPLC) | ≤ 0.5 % |
Salicylic acid (HPLC) | ≤ 0.1 % |
Methanol (GC) | ≤ 0.10 % |
Residual solvents (ICH Q3C) | excluded by manufacturing process |
Residues of metal catalysts or metal reagents acc. to EMEA/CHMP/SWP/4446/2000 are not likely to be present. Conforms to Ph Eur, BP, NF |