Assay (acidimetric; calculated on dried substance) | 99.5 - 100.5 % |
Assay (HPLC, calc.on dried substance) | 98.0 - 102.0 % |
Özdeşlik | Testi geçer |
Appearance of solution (10 %; ethanol 96 %) | Testi geçer |
Chloride (Cl) | ≤ 0.0100 % |
Sulfate (SO₄) | ≤ 0.0200 % |
Related substances / HPLC (EP) (4-Hydroxybenzoic acid) | ≤ 0.1 % |
Related substances / HPLC (EP) (4-Hydroxyisophthalic acid) | ≤ 0.05 % |
Related substances / HPLC (EP) (Phenol) | ≤ 0.02 % |
Related substances / HPLC (EP) (Largest unspecified impurity) | ≤ 0.05 % |
Related substances / HPLC (EP) (Sum of all impurities) | ≤ 0.2 % |
Related substances / HPLC (USP) (4-Hydroxybenzoic acid) | ≤ 0.1 % |
Related substances / HPLC (USP) (4-Hydroxyisophthalic acid) | ≤ 0.05 % |
Related substances / HPLC (USP) (Phenol) | ≤ 0.02 % |
Related substances / HPLC (USP) (Largest unspecified impurity) | ≤ 0.05 % |
Related substances / HPLC (USP) (Sum of all impurities) | ≤ 0.2 % |
Residual solvents (ICH Q3C) | excluded by manufacturing process |
Sulfated ash | ≤ 0.05 % |
Loss on drying | ≤ 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, USP |