Flucloxacillin Monohydrate EP Impurity F CAS 866150-92-7
| CAS No. | 866150-92-7 |
| Molecular Formula | C13H10ClFN2O4 |
| Molecular Weight | 312.68 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.
As a process- or degradation-related impurity, Flucloxacillin Monohydrate EP Impurity F (CAS 866150-92-7, C13H10ClFN2O4) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
The molecular framework of Flucloxacillin Monohydrate EP Impurity F (C13H10ClFN2O4) is characterized by a nitrogen-containing heterocyclic scaffold, 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. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.
As a certified reference material (CRM), Flucloxacillin Monohydrate EP Impurity F meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.
Physical & Chemical Properties
| Molecular Formula | C13H10ClFN2O4 |
| Molecular Weight | 312.68 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor, low volatility) |
| Purity | 97%+ |
| 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.) | 1987 |
| Halogen Content | F/Cl-containing |
| Nitrogen Atoms | 2 |
Related Flucloxacillin Standards
- Flucloxacillin RC 6 (CAS 1797824-55-5)
- Flucloxacillin RC 5 (CAS 1797982-77-4)
- Flucloxacillin RC 4 (CAS 1797891-06-5)
- Flucloxacillin RC 3 (CAS 1796928-46-5)
- Flucloxacillin EP Impurity D (CAS 3919-74-2)
- Flucloxacillin EP Impurity B (Mixture of Diastereomers) (CAS 1276016-89-7)
- Flucloxacillin EP Impurity B (CAS CATO-C4X-16472)
- Flucloxacillin - API Standards (CAS 5250-39-5)
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