|
Product name
|
Capecitabine
|
|
Molecular Formula
|
C15H22FN3O6
|
|
Molecular Weight
|
359.35
|
|
CAS No.
|
154361-50-9
|
|
Quality Standard
|
USP34, medical
grade
|
|
Appearance
|
White powder
|
|
Items
|
Specifications
|
Results
|
|
Apperance
|
White or off-white crystalline powder
|
White crystalline powder
|
|
Identification
|
The spectrum of the sample corresponds to that of RS
|
Meets the requirements
|
|
|
The retention time of the major peak of the test
solution corresponds to that of the RS
|
Meets the requirements
|
|
Specific Rotation
|
+96.0°~+100.0°
|
+98.1°
|
|
Water
|
≤0.3%
|
0.01%
|
|
Heavy Metals
|
≤20ppm
|
<20ppm
|
|
(as Pb)
|
|
Residue on ignition
|
≤0.1%
|
0.02%
|
|
Assay
|
98.0%~102.0%
|
99.70%
|
|
|
Function of Capecitabine
Capecitabine is rapidly absorbed through the intestinal mucosa after
oral administration, and then converted into an inactive intermediate
5'-deoxy-5'fluorocytidine in the liver by carboxylesterase, and then
decellularized by the liver and tumor The action of ammonia enzyme is converted
into 5'-deoxy-5 'fluorouridine, and finally catalyzed by thymidine
phosphorylase into fluorouracil (5-FU) in tumor tissue.
Clinical studies have shown that the
concentration of 5-FU in tumor tissue after oral administration of this product
is significantly higher than blood and muscle levels. The curative effect on
various animal tumors is significantly higher than that of 5-FU. This product
has a synergistic effect with a variety of anti-tumor drugs.
