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Assay (acidimetric): ≥ 99.5 %
Identity (IR-spectrum): passes test
Melting point: 128 - 132 °C
Optical rotation (20 %; water): -0.1 - 0.1 °
Fe (Iron): ≤ 0.001 %
Heavy metals (as Pb): ≤ 0.001 %
Related substances (HPLC) (Impurity A (fumaric acid)): ≤ 1.0 %
Related substances (HPLC) (Impurity B (maleic acid)): ≤ 0.05 %
Related substances (HPLC) (any other impurity): ≤ 0.1 %
Related substances (HPLC) (Sum of all other impurities): ≤ 0.5 %
