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1 Kilogram |
Negotiable |
Gemcitabine hydrochloride Gemcitabine hcl Gemcitabine
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 |
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