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Roflumilast (Daliresp) Powder | USP | PDE-4 Inhibitor

» Pharmaceutical » Respiratory System APIs » Roflumilast (Daliresp) Powder | USP | PDE-4 Inhibitor

  • Specifications

USP PDE-4 Inhibitor Powder Roflumilast (Daliresp) For Lungs Inflammatory Treatment 

 

What is Roflumilast?

Roflumilast (trade names Daxas, Daliresp) is a drug that acts as a selective, long-acting inhibitor of the enzyme 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.

 

Roflumilast Basic Information

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%
Grade Pharmaceutical Grade
Appearance white Crystalline Powder
Standard USP
Stock Mass Stock
Shelf Life 2years

 

Roflumilast Specification:

Tests Specifications Results
Characters White to off-white crystalline powder Complies
Identification IR:similar to Reference Standard Complies
Appearance of solution Clear and colorless Complies
Loss on Drying ≤0.5% 0.06%
Sulphated Ash ≤0.2% 0.03%
Heavy metals ≤0.002% Complies
Related Compouds Single Impurity ≤1.0%

Sum of Impurity≤2.0%

Undetected

Undetected

Assay(Anhydrous) 98.0% to 101.5% 100.2%

 

Roflumilast Usage

1) Roflumilast reduces inflammation in the lungs that leads to COPD (chronic obstructive pulmonary disease).

2) Roflumilast is used to prevent worsening of chronic obstructive pulmonary disease (COPD) in people with severe COPD and chronic bronchitis.

3) Roflumilast is not a bronchodilator. It will not treat a bronchospasm attack that has already begun.

 

Roflumilast side effects

Diarrhea, Weight loss, Nausea, Headache, Insomnia, Decreased appetite, Abdominal pain, Rhinitis, Sinusitis, Urinary tract infection, Depression, References

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