Capecitabine CAS NO.154361-50-9
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- Min.Order: 100 Gram
- Payment Terms: T/T
- Available Specifications:
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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 |
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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% |
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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% |
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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
|