Roflumilast Roflumilast powder 162401-32-3
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Product Name: Roflumilast
Chemical name: 3-(Cyclopropylmethoxy)-N-(3,5-dichloropyridin-4-yl)-4-(difluoromethoxy)benzamide
CAS No.: 162401-32-3
Molecular Formula:C17H14Cl2F2N2O3
Molecular Weight:403.21
Assay by HPLC (%, w/w)(on dried basis) 98.0~102.0%
Description: White powder.
Usage
The product can be used among patients with serious COPD cough and bronchial symptom related much sputum, does not apply to mild emphysema.
Quality Standard
Analysis |
Specification |
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Description |
White to off white powder. |
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Solubility |
Freely soluble in acetonitrile,soluble in chloroform and sparingly soluble in methanol |
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Identification
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The IR spectrum of the test sample preparation should be concordant with that of the standard preparation. |
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The retention time of principle peak obtained in the sample preparation should be concordant with that standard preparation in assay test. |
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Sulphated ash(%,w/w) |
≤0.2% |
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Heavy metals(ppm) |
≤20ppm |
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Melting range(℃) |
155.0~165.0℃ |
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Water content by KF(%,w/w) |
≤0.5% |
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Related substances by HPLC
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a)Single maximum impurity |
≤0.5% |
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b)Total impurities |
≤1.0% |
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Assay by HPLC (%, w/w)(on dried basis) |
98.0~102.0% |
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Residual solvent by GC(ppm)
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≤3000ppm |
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≤890 ppm |
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≤720 ppm |
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≤5000 ppm |
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≤5000 ppm |
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Particle size(um) D90 |
<75% |
Shanghai Soyoung Biotechnology Inc. a faithful and professional supplier and exporter of healthcare raw materials for pharmacy, nutrition and food industries for years with own laboratory and GMP standard factories.
Shanghai Soyoung has R&D Center and Testing Center, and has international advanced facilities of HPLC, GC, AAS, UV, TLC, LC-MS and IR equipments.
Shanghai Soyoung has nearly 20 years production experience, it is producing in GMP workshop, each batch pass strict testing before shipment. Strict quality control is performed in every procedure from material sourcing, processing and testing to packing.
We warmly welcome customers from at home and abroad to establish cooperation and create a bright future with us together. And leading the way to make health industries heathier, help more people healthy and happy…
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