Ofloxacin Impurity 48 CAS 126911-77-1
| CAS No. | 126911-77-1 |
| Molecular Formula | C21H26FN3O4 |
| Molecular Weight | 403.45 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 Ofloxacin Impurity 48.
CATO supplies Ofloxacin Impurity 48 (CAS 126911-77-1), a pharmacopoeial impurity reference standard (molecular formula C21H26FN3O4, MW 403.45 g/mol) used for the identification and quantification of trace impurities in APIs.
The molecular framework of Ofloxacin Impurity 48 (C21H26FN3O4) is characterized by a flavonoid core, an amide group, a hydroxyl group, an ether linkage, fluorine 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. 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 | C21H26FN3O4 |
| Molecular Weight | 403.45 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor) |
| Purity | >95% |
| 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.) | 1993 |
| Halogen Content | F-containing |
| Nitrogen Atoms | 3 |
Related Ofloxacin Standards
- Ofloxacin Impurity 10 (CAS 107884-32-2)
- Ofloxacin impurity 11 (CAS CATO-C4X-171711)
- Ofloxacin EP Impurity F(Levofloxacin Impurity 25) (CAS 104721-52-0)
- Ofloxacin Desethylene Impurity (CAS 1797983-25-5)
- Ofloxacin-d8 (CAS 1219170-21-4)
- (R)-Ofloxacin-d3 (CAS 1346617-10-4)
- Ofloxacin-D3 (CAS 1173147-91-5)
- Ofloxacin EP Impurity D (CAS 197291-75-1)
Recommended Standards
- Levofloxacin Impurity 46 (CAS CATO-C4X-137146)
- Gliquidone Impurity 7 (CAS CATO-C4X-30007)
- Gatifloxacin Impurity 17 (CAS 1048972-28-6)
- Boc-Met-Gly-OSu (CAS 23446-04-0)
- Amlodipine Impurity G (CAS CATO-CAB-1050)
- Dapagliflozin impurity 182 (CAS CATO-C4X-1138182)
- Eperisone Impurity 49 TFA (CAS CATO-C4X-227949)
- 4-(6-Aminopyridin-3-yl)-N-ethyl-2-fluorobenzamide (CAS 1314987-52-4)
- 2,5-Dibromo-3-cyclohexylthiophene (CAS 302912-44-3)
- (4E)-4-{[1-(2-methylpropyl)-1,2,3,4-tetrahydroquinolin-6-yl]methylidene}-2-sulfanylidene-1,3-thiazolidin-5-one (CAS 866039-79-4)
- 4-(3-Methyl-4-nitrophenoxy)piperidine (CAS 793636-66-5)
- Methyl 4-oxo-1,4-dihydroquinoline-7-carboxylate (CAS 863785-96-0)
- 2-(3-Fluoro-5-formylphenyl)acetonitrile (CAS 1379106-73-6)
- Semaglutide Impurity 21(HO-Ste-L-γGlu-AEEA-AEEA-OH) (CAS 1335440-44-2)
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