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Aktive legemidler

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Produktnavn 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%
Karakter Farmasøytisk karakter
Utseende hvitt krystallinsk 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

Varer Standarder Resultater
Utseende White or off-white solid powder Overholder
Identifikasjon By IR Overholder
By HPLC Overholder
Løselighet Highly soluble in methano,soluble in
ethanol,acetonitril; slightly soluble in water
Overholder
Smeltepunkt 156ºC~160ºC 157.6ºC~158.5ºC
Vanninnhold ≤ 0.50% 0.25%
Residue on Ignition ≤ 0.10% 0.05%
Tungt metall ≤10ppm Overholder
Resterende løsemidler Dichloromethan: ≤100ppm ND
Hexan: ≤200ppm ND
Ethyl acetat: ≤500ppm ND
Tetrahydrofura: ≤100ppm ND
Relaterte substanser 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%
Assay
(HPLC basis on drying)
98.0%~102,0 % 99.99%
Reference Standard In-house Standard
Konklusjon The product complied to In-house standard.

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