|
MF：C17H25N3O5S?3H2O
MW：437.51
structured
：
Test
|
specification |
|
1 |
Description |
Almost white to light yellow crystalline power. |
|
2 |
Identification |
1) IR:comparable IR spectra with standard spectra
2) UV: UV absorption spectrum of sample solution and standard solution should exhibit maima and minima at same wavelengh |
|
3 |
Water content(By KF) |
Between 11.4%w/w and 13.4%w/w |
|
4 |
Specific optical rotation |
-17° to -21°(at 20℃ ,OAB 0.22g/water 50ml, 100mm) |
|
5 |
Heavy metals |
Not more than 0.001%(10ppm) |
|
6 |
Residue on ignition |
Nor more than 0.1%w/w |
|
7 |
pH |
Between 4.0 and 6.0 |
|
8 |
Chromatographic
purity(%w/w,by HPLC) |
1) Hydrolysed Imp. (impurity-1) : Not more than 0.3% |
|
2) Dimeric Imp.( impurity-2) : Not more than 0.3% |
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3) Any other impurity : Not more than 0.2% |
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4) Sum of all other impurities : Not more than 1.5% ( Except Impurity-1,2) |
|
9 |
Assay (By HPLC) |
NLT 98.0%w/w(OAB) |
|
10 |
Bacterial endotoxins |
NMT 0.125 USP EU/mg |
|
11 |
%Transmittances |
NLT 40% (5%w/w solution in methanol at 420nm,Immediately) |
|
12 |
Residue on Palladium |
NMT 10ppm |
