Roflumilast Impurity 55 CAS CATO-C4X-108455
| CAS No. | CATO-C4X-108455 |
| Molecular Formula | C13H14F2O4 |
| Molecular Weight | 272.24 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
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 supplies Roflumilast Impurity 55 (CAS CATO-C4X-108455), a pharmacopoeial impurity reference standard (molecular formula C13H14F2O4, MW 272.24 g/mol) used for the identification and quantification of trace impurities in APIs.
The molecular framework of Roflumilast Impurity 55 (C13H14F2O4) is characterized by a carboxylic acid group, a hydroxyl group, an ether linkage, fluorine substitution, an aromatic ring system. In reversed-phase chromatography, its retention is governed primarily by its high hydrophobicity (logP), which provides a practical basis for HPLC-UV/DAD or LC-MS method development. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).
The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.
Physical & Chemical Properties
| Molecular Formula | C13H14F2O4 |
| Molecular Weight | 272.24 g/mol |
| Appearance | Off-white to pale yellow crystalline powder. (slight halide-like odor, low volatility) |
| Purity | 97%+ |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry, keep tightly closed to prevent evaporation |
| Solubility (reference) | Soluble in chloroform, dichloromethane, ethyl acetate, DMSO |
| 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) | 6.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | F-containing |
Related Roflumilast Standards
- Roflumilast Impurity 58 (CAS CATO-C4X-193558)
- Roflumilast impurity 15 (CAS 162401-69-6)
- Roflumilast Impurity 33 (CAS 2376345-94-5)
- Roflumilast Impurity 34 (CAS 1882067-44-8)
- Roflumilast USP Related Compound D (CAS 162401-62-9)
- Roflumilast Impurity 50 (CAS 1180526-15-1)
- Roflumilast Impurity 44 (CAS CATO-C4X-108444)
- Roflumilast Impurity C65 (CAS 162401-60-7)
Recommended Standards
- Methyl 1-((3,4,4-trifluorobut-3-en-1-yl)sulfonyl)cyclopropane-1-carboxylate (CAS 339106-70-6)
- 3-((4-Fluoro-2-nitrophenyl)amino)-2,3-dihydrothiophene 1,1-dioxide (CAS 1030178-09-6)
- Ethyl 4-(2-Ethoxy-1,1-difluoro-2-oxoethyl)benzoate (CAS 924312-34-5)
- 4-Hydroxy-2,3-dimethoxy-9H-xanthen-9-one (CAS 10527-38-5)
- Landiolol Impurity 89 (CAS CATO-C4X-262189)
- Terazosin EP Impurity O (CAS 547730-06-3)
- Fosfomycin Impurity 42 (CAS 45629-00-3（free base）)
- 5α-ANDROSTAN-3β, 11β-DIOL-17-ONE (CAS 514-17-0)
- N-(4-ethynylphenyl)-2-fluorobenzenesulfonamide (CAS 383147-79-3)
- 1-(tert-Butyl)-3-cyclopropoxy-2-methoxybenzene (CAS 1243354-61-1)
- 3-(tert-Butylamino)-4,4-dimethylisoxazol-5(4H)-one (CAS 143674-65-1)
- 7-Bromo-5-(trifluoromethyl)-3,4-dihydronaphthalen-1(2H)-one (CAS 1273673-31-6)
- 3-(3-Chloro-4-ethoxyphenyl)-3,4-dihydro-2H-benzo[b][1,4]oxazine (CAS 1708178-83-9)
- Peptide 441 (CAS CATO-CPTD788441)
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