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Home > Products >  Capecitabine

Capecitabine CAS NO.154361-50-9

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  • Min.Order: 100 Gram
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  • Product Details

Keywords

  • Capecitabine
  • 154361-50-9
  • RO-9-1978

Quick Details

  • ProName: Capecitabine
  • CasNo: 154361-50-9
  • Molecular Formula: C15H22FN3O6
  • Appearance: White OR off-white crystalline powder
  • DeliveryTime: Within 3 days
  • PackAge: 25kg/drum
  • Port: Shanghai, Hangzhou, Tianjin, Qingdao.....
  • ProductionCapacity: 200 Kilogram/Week
  • Purity: 99%
  • Storage: Normal temperature, cool, dry
  • Transportation: By air, sea, courier, according to the...
  • LimitNum: 100 Gram
  • Related Substances: 0.1
  • Residue on Ignition: 0.1
  • Heavy Metal: 20
  • Valid Period: 2018
  • Grade: Pharma Grade
  • heavy metal: 20

Superiority

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

   

 

 

Details

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

   

 

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