USD $99.00-99.00 / Kilogram
USD $1.00-10.00 / Kilogram
USD $1.00-10.00 / Kilogram
USD $1.00-10.00 / Kilogram
USD $1.00-10.00 / Kilogram
USD $8.20-8.80 / Kilogram
USD $8.20-8.80 / Kilogram
USD $4.50-5.00 / Liter
USD $1.00-10.00 / Kilogram
usp34 we have got gmp,dmf.we registered in russia.
gemcitabine hydrochloride
usp34
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 |