Grade: Pharmaceutical Grade
Factory Location: Xiamen, Fujian
Main Sales Markets: North America,Central/South America,Western Europe,Eastern Europe,Australasia,Asia,Middle East
Monthly Production Capacity: 1000kg
Packaging Information: 25kg/drum 1kg/bottle
Delivery Lead Time: 7 days after payment
Sample Provided: yes
Payment Terms: L/L
Product Information |
Product name |
Gemcitabine hydrochloride |
Molecular Formula |
C9H12ClF2N3O4 |
Molecular Weight |
299.66 |
CAS No. |
122111-03-9 |
Quality Standard |
EP / USP, medical grade |
Appearance |
White powder |
COA of Gemcitabine Hydrochloride |
Test |
Specification |
Result |
Characters |
White or almost white powder |
Conform |
Identification |
The IR spectrum of sample is concordant with the IR spectrum of Gemcitabine hydrochloride reference standard. |
Conform |
Chloride |
Conform |
|
Solubility |
Soluble in water; sparingly soluble in methanol, practically insoluble in alchohol and in polar organic solvents |
Conform |
pH |
2.0 to 3.0 |
2.2 |
Specific rotation |
+43° to +50° |
+49° |
Heavy metals |
Not more than 10ppm |
<10ppm |
Residue on ignition |
Not more than 0.1% |
0.06% |
Related substances |
Cytosine: not more than 0.1% |
0.02% |
α-anomer: not more than 0.1% |
Not detected |
|
Any other impurity: not more than 0.1% |
0.04% |
|
Total impurities: not more than 0.2% |
0.10% |
|
Bacterial endotoxins |
Not more than 0.05 EU/mg |
<0.05 EU/mg |
bacteria |
Not more than 100 CUFU/g |
<10 CFU/g |
Yeasts & Moulds |
Not more than 20 CFU/g |
<10 CFU/g |
Escherichia coli |
Not detected |
Not detected |
Residual solvents |
Methanol: not more than 0.3% |
0.0001% |
Acetone: not more than 0.5% |
0.16% |
|
Isopropyl alcohol: not more than 0.5% |
Not detected |
|
Ethylene Dichloride: not more than 5ppm |
Not detected |
|
Assay |
97.5% to 101.5% ( on as-is basis) |
99.4% |
Conclusion |
Conforms to USP34. |
|
Usage |