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Irinotecan hydrochloride

CAS No:136572-09-3
Shelf life:2 years
The detailed specifications are as below:

AppearanceAlmost white to yellow crystalline powder
Identification(A):The infrared absorption spectrum of the sample must be concordant with that of the reference substance
(B):Meets the requirements of the tests for Water
(C):It gives reaction (a)of chlorides
Appearance of solutionClarity of solution:The solution is clear
Colour of solution:Not more intensely coloured than reference solution GY2
Enantiomeric Purity/Impurity L(HPLC)Maximum 0.15 per cent
Related substances(HPLC)Impurity E:Maximum 0.15 per cent
Unspecified impurities:Maximum 0.10 per cent
Total impurities:Maximum 0.5 per cent
Residual Solvents(GC)Acetone:Not more than 5000 ppm
Methanol:Not more than 3000 ppm
Dichloromethane:Not more than 600 ppm
WaterBetween 7.0% and 9.0%
Sulfated ashMaximum 0.1 per cent
Microbial LimitsTotal aerobic microbial count:Not exceed 100 cfu/g
Total combines molds and yeasts count:Not exceed 50 cfu/g
Bacterial endotoxinsLess than 0.29 IU/mg irinotecan
Assay(HPLC)Contains NLT 98.0% and NMT 102.0% of Irinotecan Hydrochloride(C33H38N4O6·HCl),calculated on the anhydrous basis