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A typical CoA of Gemcitabine Hydrochloride is given below, please contact topharman@topharman.com for more quality items of Gemcitabine Hydrochloride.
| Product Name:
Gemcitabine Hydrochloride |
Quantity:
6kg |
CAS Registry Number:
122111-03-9
|
Lot No.: Typical |
| Molecular Formula: C9H11F2N3O4.HCl |
Molecular Weight:
299.66 |
| Structure |
 |
| Item |
Requirement |
Result |
| Description |
White crystalline granular, odorless |
White crystalline granular, odorless |
| Identification |
i, IR
ii, It meets the requirement of the tests for Chloride
|
Comply |
| Specific Rotation |
+43º- +50º |
+44.0 |
| pH Value |
2.0-3.0 |
2.60 |
| Loss on Drying |
Not more than 1.0% |
0.26% |
| Residue on Ignition |
Not more than 0.1% |
0.03% |
| Heavy Metals |
Less than 10ppm |
Comply |
Related Substances (HPLC)
a-Anomer
Cytosine
Any other individual impurity
Sum of all mpurities
|
Not more than 0.1%
Not more than 0.1%
Not more than 0.1%
Not more than 0.2%
|
Comply
Comply
Comply
0.02%
|
| Assay |
97.5-101.5% |
99.75% |
| Conclusion: |
Complies with requirements of USP29-NF24 |
|
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