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Active Pharmaceuticals

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  • Specifications
  • Product Description
  • Product Usage
  • COA
Product Name Roflumilast
Alias B 9302-107, BY 217, BYK 20869, Daxas
CAS 162401-32-3
MF C17H14Cl2F2N2O3
MW 403.21
EINECS 223-583-8
Purity 99.50%
Grade Pharmaceutical Grade
Appearance 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

Items Standards Results
Appearance White or off-white solid powder Complies
Identification By IR Complies
By HPLC Complies
Solubility Highly soluble in methano,soluble in
ethanol,acetonitril; slightly soluble in water
Complies
Melting Point 156ºC~160ºC 157.6ºC~158.5ºC
Water Content ≤ 0.50% 0.25%
Residue on Ignition ≤ 0.10% 0.05%
Heavy Metal ≤10ppm Complies
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%
Assay
(HPLC basis on drying)
98.0%~102.0% 99.99%
Reference Standard In-house Standard
Conclusion The product complied to In-house standard.

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