136572-09-3 Irinotecan hydrochloride trihydrate Irinotecan
Irinotecan hydrochloride trihydrate
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Irinotecan hydrochloride trihydrate
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TEST |
SPECIFICATIONS |
RESULT |
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ASSAY (on dried basis) |
98.0%--102.0% |
100.1% |
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CHARACTERS |
Light yellow or almost yellow,crystalline powder and odorless. |
Conforms |
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IDENTIFICATION |
The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation,as obtained in the Assay. |
Conforms |
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Infrared Absorption:In accordance with the reference Standard spectrum of Irinotecan Hydrochloride. |
Conforms |
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Meet the requirements of the identification tests for chlorides. |
Conforms |
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RESIDUE ON IGNITION |
NMT 0.1 % |
0.03 % |
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HEAVY METALS |
NMT 0.001 % |
<0.001% |
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WATER(K.F) |
7.0 %—9.0 % |
8.3 % |
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RELATED COMPOUNDS (HPLC) (on dried basis) |
7-Desethyl irinotecana≤0.15% |
Undetected |
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Irinotecan related compound Ab≤0.15% |
Undetected |
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11-Ethyl irinotecanc≤0.15% |
Undetected |
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Camptothecind≤0.15% |
Undetected |
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Irinotecan related compound Be≤0.15% |
Undetected |
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7-Ethyl camptothecinf≤0.15% |
Undetected |
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7,11-Diethyl-10-hydroxycamptothecing≤0.15% |
0.08% |
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Any unspecified impurity≤0.10% |
0.08% |
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Total impurities≤0.5% |
0.17% |
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CONCLUSION |
The product is in accordance with USP36 to test the above-mentioned items, the test results conform to the specification. |
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