| Assay (by acidimetry following saponification) |
98.0 - 102.0 % |
| Assay (HPLC) |
99.0 - 100.5 % |
| Identity |
passes test |
| Appearance of solution |
passes test |
| Acidic substances |
passes test |
| Melting range (lower value) |
≥ 96 °C |
| Melting range (upper value) |
≤ 98 °C |
| Heavy metals (as Pb) |
≤ 10 ppm |
| As (Arsenic) |
≤ 3 ppm |
| Cd (Cadmium) |
≤ 10 ppm |
| Cu (Copper) |
≤ 10 ppm |
| Hg (Mercury) |
≤ 1 ppm |
| Pb (Lead) |
≤ 2 ppm |
| Zn (Zinc) |
≤ 10 ppm |
| Related substances (HPLC) |
passes test |
| p-Hydroxy benzoic acid |
≤ 0.5 % |
| Sum of all impurities |
≤ 1.0 % |
| Largest unspecified impurity |
≤ 0.5 % |
| 1-Propylalcohol (HS-GC) |
≤ 5000 ppm |
| Other residual solvents (ICH Q3C) |
excluded by manufactoring process |
| Sulfated ash |
≤ 0.05 % |
| Loss on drying (80 °C) |
≤ 0.5 % |
| 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 (*). |
|
| Corresponds to Ph Eur, BP ,JP, NF, FCC. |
|
