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Actieve farmaceutische producten

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Productnaam Roflumilast
Alias B 9302-107, BY 217, BYK 20869, Daxas
CAS 162401-32-3
MF C17H14Cl2F2N2O3
Mw 403.21
EINECS 223-583-8
Zuiverheid 99.50%
Cijfer Farmaceutische kwaliteit
Verschijning white Crystalline Powder

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

Artikelen Standards Resultaten
Verschijning White or off-white solid powder Voldoet
Identificatie By IR Voldoet
By HPLC Voldoet
Oplosbaarheid Highly soluble in methano,soluble in
ethanol,acetonitril; slightly soluble in water
Voldoet
Smeltpunt 156ºC~160ºC 157.6ºC~158.5ºC
Waterinhoud ≤ 0.50% 0.25%
Residu bij ontsteking ≤ 0.10% 0.05%
Zwaar metaal ≤10 ppm Voldoet
Resterende oplosmiddelen Dichloromethan: ≤100ppm ND
Hexan: ≤200ppm ND
Ethyl acetat: ≤500ppm ND
Tetrahydrofura: ≤100ppm ND
Gerelateerde stoffen Impurity A: ≤0,10% 0.07%
Onzuiverheid B: ≤0,10% 0.08%
Any other single impurity: ≤0,10% 0.08%
Total Impurities: ≤0,50% 0.15%
Analyse
(HPLC basis on drying)
98.0%~102,0% 99.99%
Reference Standard In-house Standard
Conclusie The product complied to In-house standard.

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