Topotecan hydrochloride
Alias:(S)-10-[(Dimethylamino)methyl]-4-ethyl-4,9-dihydroxy-1H-pyrano[3',4':6,7]indolizino[1,2-
b]quinoline-
3,14(4H,12H)-dione monohydrochloride; Nogitecan hydrochloride; Hycamtin
Molecular structure:
Molecular formula: C23H23N3O5.HCl;C23H24ClN3O5
Molecular weight:457.91
CAS RN: 119413-54-6
hydrochloric acid拓扑替康 Quality standard:
Inspection item |
Index range |
Result |
Appearance |
light yellow or yellow crystalline powder; |
light yellow crystalline powder |
Specific optical rotation |
Specific optical rotation +91.0° to +101.0° |
+98.0° |
Acidity |
Acidity is 3.0-5.0 |
4.7 |
Residue on ignition |
is not more than 0.2％ |
qualified |
Heavy metals |
Heavy metals is not more than 20ppm |
qualified |
Assay test |
HPLC(area normalization) |
Assay |
≥98.5% |
≥99.0% |
Total impurities |
≤1.5％ |
≤1.0％ |
(S)-10-Hydroxycamptothecin |
≤0.3％ |
≤0.1％ |
Camptothecin |
≤0.3％ |
Na |
Single impurity |
≤0.5％ |
qualified |
Test of solvent residue |
GC |
ethyl alcohol |
≤5000ppm |
qualified |
Acetone |
≤5000ppm |
qualified |
dichloromethane |
≤600ppm |
qualified |
Biological test |
|
number of bacteria |
≤1000CFU/g |
qualified |
number of mildew |
≤100CFU/g |
|
Bacillus coil |
no determination |
qualified |
|
