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Gemcitabine hydrochloride

CAS No:122111-03-9
MF:C9H11F2N3O4·HCl
Shelf life:2 years
The detailed specifications are as below:

ItemsStandard
CharacteristicsWhite crystalline powder,odorless
SolubilitySoluble in water,slightly soluble in methanol,practically insoluble in acctone
Specific rotatory power+43°~+50°
Appearance of solutionSolution S in clear and not more intensely colored than reference solution BY7
Identificationa)IR:Concordant with R.S
b)CHLORIDE
Acidity(PH)2.0~3.0
Cytosine≤0.1%
Gemcitabine ɑ-anomer≤0.1%
Any individual unspecified impurity≤0.1%
Total impurities≤0.2%
Residue on ignition≤0.1%
Residual solventsMethanol≤0.03%
Acetone≤0.5%
Heavy metals≤10ppm
Bacteria<50cfu/g
Mold, Yeast<20cfu/g
E. ColiNo detected
Bacterial endotoxins<0.05EU/mg
Assay(calculated on the as-is basis)97.5%~101.5%