Roflumilast Impurity 1 CAS 162401-43-6
| CAS No. | 162401-43-6 |
| Molecular Formula | C17H14Cl2F2N2O3 |
| Molecular Weight | 403.21 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Roflumilast Impurity 1.
As a process- or degradation-related impurity, Roflumilast Impurity 1 (CAS 162401-43-6, C17H14Cl2F2N2O3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
The molecular framework of Roflumilast Impurity 1 (C17H14Cl2F2N2O3) is characterized by a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine/chlorine substitution. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.
This reference standard supports related-substances testing and method development in line with ICH Q3A/Q3B guidance on impurity control, and is suitable for system suitability testing and forced-degradation studies.
CATO manufactures Roflumilast Impurity 1 under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.
Physical & Chemical Properties
| Molecular Formula | C17H14Cl2F2N2O3 |
| Molecular Weight | 403.21 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor, low volatility) |
| Purity | 97%+ |
| Storage | Store in a cool place (≤25°C), protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in DMSO, DMF, methanol |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 10.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 2003 |
| Halogen Content | F/Cl-containing |
| Nitrogen Atoms | 2 |
Related Roflumilast Standards
- Roflumilast (CAS 162401-32-3)
- Roflumilast Impurity 29 (CAS 2368178-28-1)
- Roflumilast Impurity 53 (CAS 2204417-23-0)
- Roflumilast-d3 (CAS 1189992-00-4)
- Roflumilast -D4 (CAS 1398065-69-4)
- Roflumilast Impurity 6 (CAS 2368178-29-2)
- Roflumilast Impurity 3 (CAS 1391052-24-6)
- Roflumilast Impurity 4 (CAS 162401-30-1)
Recommended Standards
- Tributyl(5-methoxythiophen-2-yl)stannane (CAS 879480-43-0)
- Diethyl 2-(((4-iodo-2-methylphenyl)-amino)methylene)malonate (CAS 951006-38-5)
- 4-Dechloro-4-hydroxy Diclazuril Methyl Ester (CAS 1101258-51-8)
- Diethyl ((4-bromo-2-methyl-5-oxo-1-phenyl-2,5-dihydro-1H-pyrazol-3-yl)methyl)phosphonate (CAS 54813-89-7)
- Amiodarone Impurity 22 (CAS CATO-C4X-142522)
- Allisartan Isoproxil Impurity 7 (CAS CATO-C4X-32177)
- Candesartan Cilexetil EP Impurity A (CAS 139481-58-6)
- 6-Bromo-5-(trifluoromethyl)-[1,2,4]triazolo[1,5-a]pyridin-2-amine (CAS 1649478-34-1)
- 4-(2,3-Difluorophenyl)but-3-yn-1-ol (CAS 939043-50-2)
- 1236266-39-9 2-Amino-1-(4-benzyl-1-piperazinyl)-3-phenyl-1-propanone hydrochloride 2916AD C20H26ClN3O (CAS 1236266-39-9)
- (3R,5S)-5-(Methoxymethyl)pyrrolidin-3-ol (CAS 340740-51-4)
- Dicloxacillin Impurity 6 (CAS CATO-C4X-16156)
- 4-(4-Iodo-1h-pyrazol-1-yl)-2-(methylamino)butanamide (CAS 1341761-98-5)
- Insulin aspart (CAS 116094-23-6)
Why CATO?
- ISO 17034 accredited reference material producer (CNAS + ANAB dual accreditation)
- 130,000+ catalog items in stock, COA supplied with every batch
- Worldwide shipping with full export documentation (HS code guidance available)
- Technical support: +86 18665070610 / Nicole.chen@cato-chem.com