| item |
standard |
result |
| appearance |
almost white to yellow crystalline powder |
almost white crystalline powder |
| identification |
The infrared absorption spectrum of the sample must be concordant with that of the reference substance |
conforms |
| The retention time of the major peak of the sampe solution corresponds to the irinotecan(S-enantiomer)peak in the identification solution,as obtained in the test for limit of Irinotecan Hydrochloride Enantiomer |
conforms |
| Meets the requirements of the tests for Chloride |
Positive reaction |
| water aetermination |
7.0%-9.0% |
8.1% |
| chloride content |
5.0%-5.5% |
5.2% w/w |
| residue on ignition |
NMT 0.1% |
0.02% |
| heavy mrtals |
NMT 10ppm |
<10ppm |
| limit of irinotecan hrdrochloride enantiomer(HPLC) |
NMT 0.15% |
not detected |
| organic impurities (procedure 2)(HPLC) |
7-Desethyl irinotecan:not more than 0.15% |
not detected |
| Irinotecan related compound A:not more than 0.15% |
not detected |
| 11-ethyl irinotecan:not more than 0.15% |
not detected |
| camptothecin:not more than 0.15% |
not detected |
| irinotecan related compound B:not more than 0.15% |
0.002% |
| 7-ethylcanptothecin:not more than 0.15% |
0.001% |
| 7,11-Diethyl-10-hydroxy camptothecin:not more than 0.15% |
not detected |
| any unspecified impurity:not more than 0.10% |
LTDL |
| total impurities:not more than 0.50% |
0.003% |
| residual solvents(GC) |
Mtehanol:not more than 3000ppm |
130ppm |
| acetone:not more than 5000ppm |
53ppm |
| dichloromethane:not more than 600ppm |
not detected |
| peteoleum ether:not more than 100ppm |
1ppm |
| ethyl acetate:not more than 5000ppm |
not detected |
| benzene:not more than 2ppm |
not detected |
| bacterial endotoxins |
less than 0.29 EU/mg irinotecan |
<0.29EU/mg |
| microbial limits |
total aerobic microbial count:not exceed 1000 cfu/g |
<20cfu/g |
| total combined molds and yeasts count:not exceed 100 cfu/g |
<20cfu/g |
| hg |
not more than 1428ppb |
0.95ppb |
| assay(HPLC) |
contains NLT 98.0% and NMT 102.0% of Irinotecan Hydrochloride,calculated on the anhydrous basis |
99.4% |
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