Item | Quality Standards | Analysis Results | ||||
Characters | White or almost white, crystalline powder or granular crystals. Slightly deliquescent in moist air. Freely soluble in water, practically insoluble in ethanol | Pass | ||||
Identification | Pass test | Pass | ||||
Appearance of solution | Pass test | Pass | ||||
Assay | 99.0%~100.5% | 99.90% | ||||
Water | 11.0%~13.0% | 12.20% | ||||
Readily carbonisable substances | Pass test | Pass | ||||
Acidity or alkalinity | Pass test | Pass | ||||
PH (5%w/v) | 7.5~9.0 | 8.6 | ||||
Sulfate | ≤150 mg/kg | <150 mg/kg | ||||
Oxalate | ≤100 mg/kg | <100 mg/kg | ||||
Chloride | ≤50 mg/kg | <50 mg/kg | ||||
Lead | ≤1 mg/kg | <1 mg/kg | ||||
Arsenic | ≤1 mg/kg | <1 mg/kg | ||||
Mercury | ≤1 mg/kg | <1 mg/kg | ||||
Heavy metal (as Pb) | ≤10 mg/kg | <10 mg/kg | ||||
Tartrate | Pass test | Pass | ||||
Pyrogen | Pass test | Pass | ||||
Bacteria Endotoxins | Pass test | Pass | ||||
Conclusion | This batch ST2010012 complies with the standard of BP/USP/FCC/E331. |