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Active Pharmaceuticals

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  • Produktanvändning
  • COA
produktnamn Roflumilast
Alias B 9302-107, BY 217, BYK 20869, Daxas
CAS 162401-32-3
MF C17H14Cl2F2N2O3
MW 403.21
EINECS 223-583-8
Renhet 99.50%
Kvalitet Farmaceutisk kvalitet
Utseende vitt kristallint pulver

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

Föremål Standarder Resultat
Utseende White or off-white solid powder Följer
Identifiering Av IR Följer
Genom HPLC Följer
Löslighet Highly soluble in methano,soluble in
etanol,acetonitril; slightly soluble in water
Följer
Smältpunkt 156ºC~160ºC 157.6ºC~158.5ºC
Vatten innehåll ≤ 0.50% 0.25%
Residue on Ignition ≤ 0.10% 0.05%
Tungmetall ≤10 ppm Följer
Resterande lösningsmedel Dichloromethan: ≤100ppm ND
Hexan: ≤200ppm ND
Ethyl acetat: ≤500 ppm ND
Tetrahydrofura: ≤100ppm ND
Relaterade substanser Impurity A: ≤0,10 % 0.07%
Impurity B: ≤0,10 % 0.08%
Any other single impurity: ≤0,10 % 0.08%
Totala föroreningar: ≤0,50 % 0.15%
Analysera
(HPLC basis on drying)
98.0%~102.0% 99.99%
Reference Standard In-house Standard
Slutsats The product complied to In-house standard.

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