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  • technické údaje
  • Popis produktu
  • Použitie produktu
  • COA
Meno Produktu Roflumilast
Alias B 9302-107, BY 217, BYK 20869, Daxas
CAS 162401-32-3
MF C17H14Cl2F2N2O3
MW 403.21
EINECS 223-583-8
Čistota 99.50%
stupňa Farmaceutická trieda
Vzhľad biely kryštalický prášok

Roflumilast (trade names Daxas, Daliresp) is a drug that acts as a selective, long-acting inhibitor of the enzyme phosphodies phosphodiesterase-4 (PDE-4). It has anti-inflammatory effects and is used as an orally administered drug for the treatment of inflammatory conditions of the lungs such as chronic obstructive pulmonary disease (COPD).

Roflumilast is an oral selective phosphodiesterase 4 (PDE4) inhibitor. It is a benzamide compound and is currently the only phosphatase IV (PDE-4) inhibitor approved for oral treatment of respiratory diseases. Through Chemicalbook, it selectively inhibits PDE4 and blocks the transmission of inflammatory response signals, thereby inhibiting lung tissue damage caused by respiratory diseases such as COPD and asthma. It has been shown to inhibit COPD-related inflammation with a new mode of action.

Selective phosphodiesterase 4(PDE4) inhibitor. Antiasthmatic; in treatment of chronic obstructive pulmonary disease

Položky Normy Výsledky
Vzhľad White or off-white solid powder Vyhovuje
Identifikácia By IR Vyhovuje
By HPLC Vyhovuje
Rozpustnosť Highly soluble in methano,soluble in
ethanol,acetonitril; slightly soluble in water
Vyhovuje
Bod topenia 156ºC~160ºC 157.6ºC~158.5ºC
Obsah vody ≤ 0.50% 0.25%
Residue on Ignition ≤ 0.10% 0.05%
Heavy Metal ≤ 10 ppm Vyhovuje
Reziduálne rozpúšťadlá Dichloromethan: ≤100ppm ND
Hexan: ≤ 200 ppm ND
Ethyl acetat: ≤500ppm ND
Tetrahydrofura: ≤100ppm ND
Súvisiace látky Impurity A: ≤ 0,10 % 0.07%
Impurity B: ≤ 0,10 % 0.08%
Any other single impurity: ≤ 0,10 % 0.08%
Celkové nečistoty: ≤ 0,50 % 0.15%
Skúška
(HPLC basis on drying)
98.0%~102,0 % 99.99%
Reference Standard In-house Standard
Záver The product complied to In-house standard.

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