Levofloxacin EP Impurity B HCl CAS 2254176-11-7
| CAS No. | 2254176-11-7 |
| Molecular Formula | C17H18FN3O4 |
| Molecular Weight | N/A |
| 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 Levofloxacin EP Impurity B HCl (CAS 2254176-11-7), a pharmacopoeial impurity reference standard (molecular formula C17H18FN3O4HCl, MW 383.80 g/mol) used for the identification and quantification of trace impurities in APIs.
The molecular framework of Levofloxacin EP Impurity B HCl (C17H18FN3O4HCl) is characterized by a flavonoid 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. 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 | C17H18FN3O4 HCl |
| Molecular Weight | 383.80 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor, low volatility) |
| Purity | >90% |
| Storage | Store at 2-8°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) | 9.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1998 |
| Halogen Content | F/Cl-containing |
| Nitrogen Atoms | 3 |
Related Levofloxacin Standards
- Levofloxacin (CAS 100986-85-4)
- Levofloxacin R-Isomer（Levofloxacin EP Impurity A） (CAS 100986-86-5)
- Levofloxacin EP Impurity F (CAS 100986-89-8)
- Levofloxacin Impurity 35 (CAS 1012310-27-8)
- Levofloxacin Impurity 51 (CAS 1026952-91-9)
- Levofloxacin Impurity N27 (CAS 1036016-10-0)
- Levofloxacin Impurity 100 (CAS 104600-15-9)
- Levofloxacin Impurity 101 (CAS 105804-40-8)
Recommended Standards
- Bilastine Impurity 55 (CAS CATO-C4X-225355)
- Insulin Degludec Impurity 20 (CAS CATO-C4X-215720)
- Enarodustat Impurity 27 (CAS CATO-C4X-322827)
- 3-(Pyridin-4-yl)-6-(trifluoromethyl)pyridin-2-ol (CAS 1214362-72-7)
- Tert-butyl (1S,6S,7R)-7-(trifluoromethyl)-2-azabicyclo[4.1.0]Heptane-2-carboxylate (CAS 1623162-53-7)
- 3-(1-Propylpyrrolidin-2-yl)pyridin-2-amine (CAS 1352522-34-9)
- 4-Fluoro-2-(thiazol-4-yl)phenol (CAS 1387563-11-2)
- 3-(((4-Fluorophenyl)thio)methyl)piperidine hydrochloride (CAS 1289385-78-9)
- 3,4-Dihydro-2h-1,5-benzodioxepine-7-sulfonamide (CAS 874842-53-2)
- Insulin Degludec Impurity 6 (CAS CATO-C4X-21576)
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