Pó de Capecitabina de alta qualidade USP35 154361-50-9 em estoque

Test Items

Standard

Results

Appearance

White to off-white crystalline powder

Conforms

 Solubility

Freely soluble in methanol;soluble in acetonitrile

 and in alcohol;sparingly soluble in water

Conforms

Identification

A.By IR spectrum.

IR spectrum sample should concordant with

 spectrum of standard

B.By HPLC.

The retention time of the major peak of the

 sample solution corresponds to that of the

 standard solution,as obtained in the Assay.

Conforms

Conforms

Water

Not more than 0.3%

0.05%

Optical Rotation

+96.0°~  +100.0°

 +96.8°

Heavy metals 

Not more than 20ppm

Conforms

Residue on ignition

Not more than 0.1%

0.03%

Related compounds

Capecitabine related compound A≤0.3%

0.001%

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-butyloxy

carbonyl) cytidine≤0.5%

0.004%

[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%

N.D.

Capecitabine related compound C≤0.3%

0.02%

[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%

0.01%

Individual unspecified impurity≤0.1%

0.02%

Total unspecified impurities≤0.5%

0.04%

Total impurities≤1.5%

0.08%

Residual solvents by GC

 Methanol ≤3000ppm 

 Ethanol ≤5000ppm 

 Ethyl acetate ≤5000ppm 

 Toluene ≤890ppm 

 Pyridine ≤200ppm 

 Hexane ≤290ppm 

 Dichloromethane ≤600ppm

200ppm

1ppm

20ppm

3ppm

7ppm

6ppm

40ppm

Assay 

 (HPLC)

98%-102.0%

(Calculated on the anhydrous and solvent-free basis)

99.8%