Specifications:
|
Item |
Specification （USP26） |
Results |
|
Appearance |
White crystals or crystalline powder |
Conforms |
|
Specific rotation |
-84.3° to -86.3° |
-85.6° |
|
Chloride(Cl) |
Not more than 0.050% |
Less than 0.050% |
|
Sulfate(SO4) |
Not more than 0.030% |
Less than 0.030% |
|
Iron(Fe) |
Not more than 30ppm |
Less than 30ppm |
|
Heavy metals(Pb) |
Not more than 15ppm |
Less than 15ppm |
|
Chromatographic purity |
Individual impurity not more than 0.5% and total impurities not more than 2.0% |
Conforms |
|
Loss on drying |
Not more than 0.40% |
0.28% |
|
Residue on ignition(sulfated) |
Not more than 0.40% |
0.32% |
|
Assay |
98.5% to 101.5% |
99.80% |