| Test Items | Specifications | Result |
| Appearance | White to off-white crystalline powder. | Off-white crystalline powder |
| Solubility | Free soluble in methanol; soluble in Acetonitrile and in alcohol. Sparingly soluble in water. | Conforms |
| Identification | Infrated Absorption | Conforms |
| Retention time of the major peak in the chromatogram of assay corresponds to that in the chromatogram of the reference standard. | Conforms | |
| Water Determination | ≤0.3% | 0.02% |
| Optical Rotation | +96.0° ~ +100.0° | +97.5° |
| Residue on Ignition | ≤0.1% | 0.01% |
| Heavy metals | ≤20ppm | Conforms |
| Related substances | Capecitabine related compound A≤0.3% | ND |
| Capecitabine related compound B≤0.3% | 0.03% | |
| 2,3-Di-O-acetyl-5′-deoxy-5-fluorocytidine≤0.10% | 0.02% | |
|
5-Deoxy-5-fluoro-N4-(2-methyl-1-butyloxycarbonyl)cytidine + 5-Deoxy-5-fluoro-N4-(3-methyl-1-butyloxycarbonyl)cytidine
≤0.5% |
ND | |
| [1-[5-Deoxy-3-O-(5-deoxy-β-D- ribofuranosyl )-β-D- ribofuranosyl ]-5-fluoro-2-oxo-1,2-dihydropyrimidin-4-yl]- carbamic acid pentyl ester≤0.3% | ND | |
| [1-[5-Deoxy-2-O-(5-deoxy-β-D- ribofuranosyl )-β-D- ribofuranosyl ]-5-fluoro-2-oxo-1,2-dihydropyrimidin-4-yl]-carbamic acid pentyl ester≤0.2% | ND | |
| Capecitabine related compound C≤0.3% | ND | |
| [1-[5-Deoxy-2-O-(5-deoxy-β-D- ribofuranosyl )-α-D- ribofuranosyl ]-5-fluoro-2-oxo-1,2-dihydropyrimidin-4-yl]-carbamic acid pentyl ester≤0.3% | ND | |
| 2,3-Di-O-acetyl-5-deoxy-5-fluoro-N4-(pentyloxycarbonyl) cytidine≤0.1% | ND | |
| Individual unspecified impurity≤0.1% | 0.03% | |
| Total impurities≤1.5% | 0.10% | |
| Assay | 98.0%~102.0% on the anhydrous and solvent-free basis | 99.9% |
|
Packaging and storage:
Preserve in tight containers. Store at controlled room temperature. |
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| Shipping Terms | ||
| By Express | By Air | By Sea |
|
Suitable for under 50kg
Fast:3-4 days High cost Door to door service Easy to pick up the goods |
Suitable for more than 50kg
Fast:3-4 days High cost Airport to airport Professional broker needed |
Suitable for more than 500kg
Slow:15-30 days Low cost Port to port Professional broker needed |