Introduzzjoni fil-qosor tal-prodott
Isem tal-Prodott: Capecitabine
CAS: 154361-50-9
MF: c15H22Fn3O6
MW: 359.35
Speċifikazzjoni tal-prodott
|
Dehra |
Abjad għal Off - White Crystalline Power |
|
Identifikazzjoni |
IR: L-ispettru ta 'assorbiment infra-aħmar tal-kampjun jikkonforma mal-istandard ta' referenza. |
|
|
HPLC: Il-ħin taż-żamma tal-quċċata ewlenija tas-soluzzjoni tal-kampjun jikkorrispondi għal dak tas-soluzzjoni standard, kif miksub fl-assaġġ. |
|
Rotazzjoni speċifika (20 grad, fuq l-anidru u s-solvent - bażi b'xejn) |
+96.0 grad ~ +100.0 grad |
|
Umdità |
Inqas minn jew daqs 0.3% |
|
Residwi fuq l-ignition |
Inqas minn jew daqs 0.1% |
|
Sustanzi relatati |
Impurità inqas minn jew daqs 0.3% |
|
|
Impurità B inqas minn jew daqs 0.3% |
|
Sustanzi relatati |
Impurità C inqas minn jew daqs 0.3% |
|
|
Impurità waħda mhux speċifikata inqas minn jew daqs 0.1% |
|
|
Impuritajiet totali mhux speċifikati inqas minn jew daqs 0.5% |
|
|
Impuritajiet totali inqas minn jew daqs 1.5% |
|
Metalli tqal |
Inqas minn jew daqs 0.002% |
|
Solventi residwi |
Etanol inqas minn jew daqs 5000ppm |
|
|
Metanol inqas minn jew daqs 3000ppm |
|
|
Dichloromethane inqas minn jew daqs 600ppm |
|
|
Aċetat tal-etil inqas minn jew daqs 5000ppm |
|
|
Toluene inqas minn jew daqs 890ppm |
|
|
Piridina inqas minn jew daqs 200ppm |
|
|
n - hexane inqas minn jew daqs 290ppm |
|
|
2 ', 3' - di - o - acetyl - 5'-deoxy-5-fluorocytidine inqas minn jew daqs 0.1% |
|
|
5 '- deoxy - 5 - fluoro - n4- (2-methyl-1-butyloxycarbonyl) cytidine +5' - deoxy-5-fluoro-n4- (3-methyl-1- Butyloxycarbonyl) cytidine inqas minn jew daqs 0.5% |
|
|
[5 - deoxy - 3 - o - (5 {-}} deoxy {- beta - d {{{{ 15}} ribofuranosyl) -beta-d-ribofuranosyl] -5-fluoro-2-oxo-1, 2-dihydropyrimidin-4-yl] - Aċidu karbamiku pentyl ester inqas minn jew daqs 0.3% |
|
|
[5 - deoxy - 2 - o - (5 {-} deoxy {- beta - d {{{{ 15}} ribofuranosyl) -beta-d-ribofuranosyl] -5-fluoro-2-oxo-1, 2-dihydropyrimidin-4-yl] - Aċidu karbamiku pentyl ester inqas minn jew daqs 0.2% |
|
|
[1 - [5 - deoxy - 3 - o {- (5-deoxy-alpha-d-ribofuranosyl) - Beta - d - ribofuranosyl] - 5-fluoro-2-oxo-1,2-dihydropyrimidin-4-yl] - - - Aċidu karbamiku pentyl ester inqas minn jew daqs 0.3% |
|
|
2 ', 3' - di - o - acetyl - 5 '- deoxy-5-fluoro-n4- (pentyloxycarbonyl) cytidine inqas minn jew ugwali għal 0.1% |
|
Metalli tqal |
Inqas minn jew daqs 0.002% |
|
Solventi residwi |
Etanol inqas minn jew daqs 5000ppm |
|
|
Metanol inqas minn jew daqs 3000ppm |
|
|
Dichloromethane inqas minn jew daqs 600ppm |
|
|
Aċetat tal-etil inqas minn jew daqs 5000ppm |
|
|
Toluene inqas minn jew daqs 890ppm |
|
|
Piridina inqas minn jew daqs 200ppm |
|
|
n - hexane inqas minn jew daqs 290ppm |
|
Għadd mikrobjali aerobiku totali |
Inqas minn jew daqs 200cfu / g |
|
Ħmira & Forom |
Inqas minn jew daqs 50cfu / g |
|
E.Coli |
Ma nstabx |
|
Test(fuq l-anidru u solvent -Bażi b'xejn) |
98.0% ~ 102.0% |
