Fexofenadine EP Impurity F(HCl) CAS CATO-C4X-17948
| CAS No. | CATO-C4X-17948 |
| Molecular Formula | C31H37NO4 |
| Molecular Weight | N/A |
| 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 Fexofenadine EP Impurity F(HCl).
CATO supplies Fexofenadine EP Impurity F(HCl) (CAS CATO-C4X-17948), a pharmacopoeial impurity reference standard (molecular formula C31H37NO4HCl, MW 524.10 g/mol) used for the identification and quantification of trace impurities in APIs.
Based on its molecular formula C31H37NO4HCl, Fexofenadine EP Impurity F(HCl) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, chlorine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 524.10 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.
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.
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 | C31H37NO4 HCl |
| Molecular Weight | 524.10 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor) |
| Purity | >90% |
| Storage | Store at room temperature, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in methanol, acetonitrile, DMSO, water (slightly soluble) |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 13.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 1 |
Related Fexofenadine Standards
- Fexofenadine Impurity 13 (CAS 1010812-98-2)
- Fexofenadine EP Impurity E (CAS 115-46-8)
- Fexofenadine EP Impurity G (CAS 1187954-57-9)
- Fexofenadine Impurity 23 (CAS 1208313-13-6)
- Fexofenadine-d10 HCl (CAS 1215821-44-5)
- Fexofenadine-d6 Methyl Ester (CAS 1286458-00-1)
- Fexofenadine Impurity 11 (CAS 1347311-10-7)
- Fexofenadine Impurity 40 (CAS 1390644-37-7)
Recommended Standards
- Barloxavir impurity 99 (CAS CATO-C4X-210899)
- Ticagrelor Impurity 107 (CAS 155899-66-4)
- Enrofloxacin EP Impurity C HCl (CAS 138892-82-7 (Free Base))
- 6-Aminophenazine-1-carboxylic acid (CAS 91804-63-6)
- Copper(II) 8-methylnonanoate (CAS 84082-88-2)
- N-Benzyl-3-methoxybenzamide (CAS 82082-48-2)
- 3-(4-Chloro-5-methyl-1h-pyrazol-1-yl)propan-1-ol (CAS 180741-40-6)
- 4-{[(3-chlorophenyl)amino]methylidene}-4,5-dihydro-1H-pyrazol-5-one (CAS 338777-75-6)
- 2-Chloro-7-fluoro-3-quinolinecarboxylic acid (CAS 1017157-81-1)
- Tirzepatide Impurity 59 (CAS CATO-C4X-324059)
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