| Assay (acidimetric; calculated on dried substance) |
99.5 - 100.5 % |
| Assay (HPLC, calc.on dried substance) |
98.0 - 102.0 % |
| Identity |
passes test |
| Appearance of solution (10 %; ethanol 96 %) |
passes test |
| Chloride (Cl) |
≤ 0.0100 % |
| Sulphate (SO₄) |
≤ 0.0200 % |
| Heavy metals (as Pb) |
≤ 0.0020 % |
| 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 |
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