Complaint
| 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. | |||||
