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Gemcitabine hydrochloride cas:122111-03-9 Gemcitabine hydrochloride Gemcitabine Gemcitabine HCl Gemcitabine hydrochloride
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CERTIFICATE OF ANALYSIS
Product name |
Gemcitabine HCl |
Inspection Items |
Accepted Standard |
Results |
Appearance |
White crystalline powder, odorless dissolve in water slightly dissolve in ethanol, hardly dissolve in chloroform and acetone |
Complies |
Identification |
A: By IR, The graph of test solution should conforms with working standard. |
Complies |
B: Chloride, it meets the requirements of the tests for chloride |
Complies |
|
Specific rotation |
+43°~ +50° |
+47.8° |
pH |
2.0-3.0 |
2.67 |
Cytosine |
£ 0.1 % |
0.003% |
Isomer |
£ 0.1 % |
0.002% |
Sum of impurities |
£ 0.2 % |
0.03% |
Residue on ignition |
£ 0.1% |
0.01% |
Heavy metals |
£ 10ppm |
Complies |
Assay |
97.5%-101.5%, calculated on dried base |
99.2% |
Conclusion :Complies to the standard USP34 |
Analyst :liyuling Checker: wuhao Supervisor :wangsulan
Identification | ||
Name | Gemcitabine hydrochloride | |
Synonyms | 4-Amino-1-[3,3-difluoro-4-hydroxy-5-(hydroxymethyl)tetrahydrofuran-2-yl]-1H-pyrimidin-2-one hydrochloride | |
Molecular Structure | ||
Molecular Formula | C9H11F2N3O4.HCl | |
Molecular Weight | 299.66 | |
CAS Registry Number | 122111-03-9 |
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