Capecitabine CAS 154361-50-9

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Model: MOS154361-50-9
Brand Name: MOSINTER
CAS No.: 154361-50-9
Purity: 99% MIN
Molecular formula: C9H12FN3O4
Molecular weight: 245.2077
Boiling point: 437.874°C at 760 mmHg
Flashing point: 218.619°C
Storage condition: -20°C Freezer
Density: 1.841g/cm3
Alias: Xeloda
Category:

Capecitabine (CAS: 154361-50-9)

Contents Specification Results
Characters White or almost white powder White powder
Solubility     Freely soluble in methanol;soluble in   acetonitrile 

and in alcohol;sparingly soluble in water

 Conforms
Identification A:Infrared Absorption Conforms
B:the retention time of the major peak in   the chromatogram

 of the Assay preparation corresponds to that in the   chromatogram 

of the Standard preparation,as obtained in the Assay

 Conforms
Water Not more than 0.3% 0.0005
Specific rotation +96.0°~   100.0° +96.8°
Residue on ignition ≤   0.1% 0.0003
Heavy metals Not more than 20ppm Conforms
Related compounds Capecitabine related compound A≤0.3% 0.00001
Capecitabine related compound B≤0.3% N.D.
2′,3′-Di-O-acetyl-5′-deoxy-5-fluorocytidine≤0.1% N.D.
5′-Deoxy-5-fluoro-N4-(2-methyl-1-butyloxycarbonyl)cytidine+5′-Deoxy-5-fluoro-N4-(3-methyl-1-butyloxycarbonyl) cytidine≤0.5% 0.00004
[1-[5-Deoxy-3-O-(5-β-D-ribofuranosyl)- β-D-ribofuranosyl]-5-fluoro-2-oxo-1,2-dihydropyrimidin-4-yl]-carbamic   acid pentylester≤0.3% N.D.
[1-[5-Deoxy-2-O-(5-β-D-ribofuranosyl)- β-D-ribofuranosyl]-5-fluoro-2-oxo-1,2-dihydropyrimidin-4-yl]-carbamic   acid pentylester≤0.2% N.D.
Capecitabine related compound C≤0.2% 0.0002
[1-[5-Deoxy-2-O-(5-α-D-ribofuranosyl)- β-D-ribofuranosyl]-5-fluoro-2-oxo-1,2-dihydropyrimidin-4-yl]-carbamic   acid pentyl este≤0.3% 0.01%.
2′,3′-Di-O-acetyl-5′-deoxy-5-fluoro-N4-(pentyloxycarbonyl)   Cytidine≤0.1% N.D.
Individual   unspecified impurity≤0.1% 0.0002
Total   unspecified impurities≤0.5% 0.0004
Total   impurities≤1.5% 0.0008
Residual solvent Ethyl   Acetate  ≤5000ppm 20ppm
Methanol  ≤3000ppm 200ppm
Ethanol   ≤5000ppm 1ppm
Pyridine   ≤200ppm 7ppm
Hexane ≤290ppm 6ppm
Dichloromethane   ≤600ppm 40 ppm
Toluene   ≤890ppm  3ppm
Assay 98%-102.0% (Calculated on the anhydrous and   solvent-free basis) 0.998
Conclusion: It complies with the   requirements of the USP34


Melting point:110-121 ℃
Related Information:

Loss on drying:≤1.0%

Application:

Mainly used for primary or metastatic breast cancer, rectal cancer, colon cancer and stomach cancer treatment.

It is used in the treatment of the following cancers:

  • Colorectal cancer (either adjuvant therapy or for metastatic cases)
  • Breast cancer (metastatic or as monotherapy/combotherapy; this is licensed as a second-line treatment in the UK)
  • Gastric cancer (off-label in the US; this is a licensed indication in the UK)
  • Oesophageal cancer (off-label in the US)

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