Capecitabine

Name of product：Capecitabine     

Batch No.20130112

Mfg. Date：20130120

Test Items

Standard

Results

Identification

A:Infrared Absorption

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

Conform

Conform

Characteristics

White or almost white powder 

White powder

Water

Not more than 0.3%

0.18%

Specific rotation

+96.0°~ 100.0°

+99.6°

Heavy metals 

Not more than 20ppm

 Conform

Related compounds

Capecitabine related compound A≤0.3%

0.03%

Capecitabine related compound B≤0.3%

0.04%

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-butyloxy

carbonyl) cytidine≤0.5%

N.D.

[1-[5-Deoxy-3-O-(5-β-D-ribofuranosyl)- β-D-ribofuranosyl]

-5-fluoro-2-oxo-1,2-dihydropyrimidin-4-yl]-carbamic acid pentyl

ester≤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 pentyl

ester≤0.2%

0.01%

Capecitabine related compound C≤0.2%

0.01%

[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%

N.D.

2’,3’-Di-O-acetyl-5’-deoxy-5-fluoro-N4-(pentyloxycarbonyl)

Cytidine≤0.1%

N.D.

Individual unspecified impurity≤0.1%

0.01%

Total unspecified impurities≤0.5%

0.08%

Total impurities≤1.5%

0.2%

Residual solvent

  Ethyl Acetate  ≤5000ppm

20ppm

  Methanol  ≤3000ppm 

10ppm

  Isopropanol ≤5000ppm

N.D.

  Chloromethane  ≤600ppm 

N.D.

  Toluene ≤890ppm  

40ppm

Purity

≥ 98.5%

99.8%

Conclusion: complies with USP34