描述
MELTING POINT: 238 °C
SOLUBILITY: water 22 g/l at 20 °C
PHYSICAL DESCRIPTION: solid
SPECIFICATIONS:
Assay (Perchl. Ac.) calc. a.d.s.: 98.5-101.5 %
Identity according to Pharmacopoeias:: passes test
Melting range (a.d.s.): 234-239°C
Maximum limit of impurities
Appearance of solution: passes test
Acidity: passes test
Insoluble matter in H2O: passes test
Loss on drying: 0.5%
Residue on ignition (as SO4): 0.1 %
Sulfate (SO4): 0.05%
Related Substances (HPLC)
Individual impurity: 0.10%
Total impurities: 0.1%
Chromatographic purity: passes test
Residual solvents (Ph.Eur/USP): passes test
Heavy metals (as Pb): 0.001%
As: 0.0003 %
Cu: 0.001 %
Fe: 0.002 %
Ni: 0.001 %
Pb: 0.001 %
Residual metals (according to EMEA/CHMP/SWP/4446/2000): Nickel compounds as metal catalyst (class 1C classification) can be present. It is below to 0,2 ppm. It is fully in compliance with the EMEA guideline.
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