China GMP Factory Direct Supply 99% Purity USP Grade Roflumilast Powder CAS: 162401-32-3, Find details about China Roflumilast, Roflumilast Powder from China GMP Factory Direct Supply 99% Purity USP Grade Roflumilast Powder CAS: 162401-32-3
Roflumilast is a selective oral phosphodiesterase-4 (PDE-4) inhibitor and a benzamide compound. It was developed by the German company Altana in 1993 and is the only oral PDE-4 inhibitor used to treat respiratory tract diseases approved for sale. Roflumilast is the first drug of its kind to target severe chronic obstructive pulmonary disease (COPD), and it is also the first oral anti-inflammation drug specifically developed for COPD patients. Its unique properties can help regulate COPD: when used in combination with bronchodilators to treat extremely severe COPD patients, roflumilast can has the advantage of further reducing symptoms and deterioration rate, thus making it the first drug that targets patients with recurring deteriorating phenotype-specific COPD and severe air flow obstruction related to chronic coughing and excess phlegm. Besides being a treatment for severe COPD, roflumilast can also be used to prevent and treat livestock respiratory tract diseases, excess mucosa bronchitis cough, asthmatic bronchitis, and acute bronchitis and air sacculitis accompanied by abnormal respiratory tract secretion.
Items | Standards | Results | |
Appearance | White or off-white solid powder | Complies | |
Identification | By IR | Complies | |
By HPLC | Complies | ||
Solubility | Highly soluble in methanol,soluble in ethanol,acetonitrile; 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 | Dichloromethane: ≤100ppm | ND | |
Hexane: ≤200ppm | ND | ||
Ethyl acetate: ≤500ppm | ND | ||
Tetrahydrofuran: ≤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 |
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