escription |
a white to off wihte cystalline powder ;odorless;tasted bitter |
a white to off wihte cystalline powder; odorless; tasted bitter |
|
identification |
a.ir |
conform to reference standard |
conforms |
|
b.chemical property |
dissolve 0.1g the sample with 10 ml water,add 5ml dinitro-phenyl-hydrazine,should have marron precipitate |
positive |
|
c.hplc |
hplc rt of sample is the same as working standard |
conforms |
loss on drying |
≤1.0% |
0.45% |
|
residual on ignition |
≤0.10% |
0.06% |
|
heavy metals |
≤0.002% |
complies |
|
impurity by hplc any impurity(max) total impurities |
≤0.1% ≤0.3% |
≤0.04% ≤0.09% |
|
residual solvents ethyl acetate acetone dmso |
≤0.5% ≤0.5% ≤0.5% |
complies complies complies |
|
assay(hplc) |
98.50~102.00% |
99.35% |