Complaint
Item | Quality Standards (BP USP FCC E331) | ||||
Characters | White or almost white, crystalline powder or granular | ||||
Identification | Pass test | ||||
Appearance of solution | Pass test | ||||
Assay | 99.0%~100.5% | ||||
Water | 11.0%~13.0% | ||||
Readily carbonisable substances | Pass test | ||||
Acidity or alkalinity | Pass test | ||||
PH (5%w/v) | 7.5~9.0 | ||||
Sulfate | ≤150 mg/kg | ||||
Oxalate | ≤100 mg/kg | ||||
Chloride | ≤50 mg/kg | ||||
Lead | ≤1 mg/kg | ||||
Arsenic | ≤1 mg/kg | ||||
Mercury | ≤1 mg/kg | ||||
Heavy metal (as Pb) | ≤10 mg/kg | ||||
Tartrate | Pass test | ||||
Pyrogen | Pass test | ||||
Bacteria Endotoxins | Pass test | ||||
