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| Irinotecan hydrochloride trihydrate |
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 trihydrate
Molecular structure:
Molecular formula:C33H38N4O6.HCl.3(H2O)
Molecular weight:677.19
CAS RN:136572-09-3
| Irinotecan hydrochloride
Quality standard:(Chinese Standard):WS1-(X-339)-2003Z |
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 |
Moisture |
Moisture is 7.0％ to 9.5％ |
9.0％ |
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) |
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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 |
pyridine |
≤0.02％ |
qualified |
Benzene |
≤0.0002％ |
Na |
Toluene |
≤0.089％ |
Na |
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