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Productos farmacéuticos activos

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  • Descripción del producto
  • Uso del producto
  • COA
nombre del producto Roflumilast
Alias B 9302-107, BY 217, BYK 20869, Daxas
CAS 162401-32-3
FM C17H14Cl2F2N2O3
megavatios 403.21
EINECS 223-583-8
Pureza 99.50%
Calificación Grado farmacéutico
Apariencia polvo cristalino blanco

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) inhibidor. 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) inhibidor. Antiasthmatic; in treatment of chronic obstructive pulmonary disease

Elementos Estándares Resultados
Apariencia White or off-white solid powder Cumple
Identificación By IR Cumple
By HPLC Cumple
Solubilidad Highly soluble in methano,soluble in
ethanol,acetonitril; slightly soluble in water
Cumple
Punto de fusion 156ºC~160ºC 157.6ºC~158.5ºC
Contenido de agua ≤ 0.50% 0.25%
Residue on Ignition ≤ 0.10% 0.05%
Heavy Metal ≤10 ppm Cumple
Residual Solvents Dichloromethan: ≤100ppm ND
Hexan: ≤200ppm ND
Ethyl acetat: ≤500ppm ND
Tetrahydrofura: ≤100ppm ND
Related Substances Impurity A: ≤0.10% 0.07%
Impurity B: ≤0.10% 0.08%
Any other single impurity: ≤0.10% 0.08%
Total Impurities: ≤0.50% 0.15%
Ensayo
(HPLC basis on drying)
98.0%~102.0% 99.99%
Reference Standard In-house Standard
Conclusión The product complied to In-house standard.

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