Gemcitabine HCl

Test items

Quality requirements            

Results

[Description]

White or almost white powder

Complies

Solubility

Soluble in water, slightly soluble in methanol, practically insoluble in acetone

Complies

[Identification]

A

Infrared Absorption 

Complies

B

It meets the requirements of the tests for Chloride 

Complies

[Tests]

pH

2.0 to 3.0

2.2

Specific optical

Rotation

+43.0° to + 50.0°

+49.0°

Related substances

Impurity A ≤ 0.1%

α-anomer ≤ 0.10%

Unspecified impurities ≤ 0.10%

Total  ≤ 0.2%

0.01%

Not detected

0.04%

0.10%

Heavy metals

≤10ppm

Complies

Sulphated ash

≤0.1%

0.06%

Bacterial endotoxins

≤0.05IU/mg

Complies

Residual solvents 

Petroleum ether- none detected

acetone≤0.5%

tetrahydrofuran≤0.072%

ethyl acetate≤0.5%

methanol≤0.3%

dichloromethane≤0.06%

acetonitrile≤0.041%

anisole≤0.5%

triethylamine≤0.032%

Not detected

0.16%

Not detected

Not detected

0.0001%

Not detected

Not detected

Not detected

Not detected

[Assay]

97.5% to 101.5%

99.4%