Alias: (S)-[1,4'-Bipiperidine]-1'-carboxylic acid, 4,11-diethyl-3,4,12,14-tetrahydro-4-hydroxy-3,14-dioxo-
1H-pyrano[3',4':6,7]indolizino[1,2-b]quinolin-9-yl ester hydrochloride
Molecular structure
Molecular formula: C33H38N4O6.HCl
Molecular weight: 623.15
CAS RN: 100286-90-6
Irinotecan hydrochloride Quality standard:
Inspection item |
Index range |
Result |
| Appearance |
light yellow or yellow crystalline powder |
slight light yellow to off-white crystalline powder |
Specific optical rotation |
Specific optical rotation +63.0°to +69.0° |
+65.0° |
Acidity |
Acidity is 3.0-5.0 |
4.7 |
Color of solution |
not darker than 4# yellow green standard liquid |
qualified |
Residue on ignition |
is not more than 0.1% |
qualified |
Heavy metals |
Heavy metals is not more than 20ppm |
qualified |
Assay test |
HPLC(area normalization) |
Assay |
≥99% |
99.9% |
Total impurities |
≤1% |
0.1% |
7-ethylcamptothecin |
≤0.3% |
Na |
7-Ethyl-10-hydroxycamptothecin |
≤0.3% |
Na |
Single impurity |
≤0.3% |
qualified |
Test of solvent residue |
GC |
dichloromethane |
≤0.06% |
Na |
trichloromethane |
≤0.006% |
qualified |
|
