ITEMS | SPECIFICATIONS |
Solubility in Water | Freely Soluble |
Solubility in Ethanol | Slightly Soluble |
Ultraviolet Absorption | 227±2nm |
Test for Potassium | Positive |
Precipitation test | Yellow Precipitate |
Assay Content % | 99.0~101.0 |
Loss on Drying(105ºC,2h) % | ≤1 |
Particle Size mesh | 20-100 |
Organic Impurities μg/g | ≤20 |
Impurity A % | ≤0.125 |
Impurity B mg/kg | ≤20 |
Fluoride mg/kg | ≤3 |
Heavy Metals mg/kg | ≤5 |
Arsenic mg/kg | ≤3 |
Lead mg/kg | ≤1 |
Sulfate % | ≤0.1 |
PH | 5.5-7.5 |
Impurity A:3-oxobtanamide(acctylacetamide) | |
Impurity B:5-chloro-6-methyl-1,2,3-oxathiazin-4(3H)-one 2,2-dioxide |