Gemcitabine hydrochloride 98.0%min USP34 Pharmaceutical Anti cancer drugs China CAS NO.122111-03-9

Characteristics

White to off-white solid

Solubility

Soluble in water,very slightly soluble in methanol,practically insoluble in alcohol and in polar organic solvents

Identification 

A）IR ：Concordant with R.S 

B）Chloride：

Specific rotatory power

+43 ～ +50º 

Acidity (PH)

2.0~3.0  

Residue on ignition

≤0.1%

Heavy metals

≤10ppm

Cytosine

≤0.1% 

Gemcitabine α-anomer

≤0.1% 

Any other impurity

≤0.1%

Sum of all impurities

≤0.2%  

Assay

97.5~101.5% 

Total bacteria quantity

<100 cfu/g

Mold total yeast

<20 cfu/g

Escherichia coli

No detected

Bacterial endotoxins

≤0.05% IU/mg

Residual solvents

Methanol：≤3000ppm

Acetone：≤5000ppm

Isopropyl alcohol：≤5000ppm

Acetonitrile：≤410ppm

Ethyl acetate：≤600ppm

Methylene chloride：≤5000ppm

Tetrahydrofuran：≤720ppm

Toluene：≤890ppm

Residual Benzene：≤2ppm