Sitafloxacin Impurity 1 CAS CATO-C4X-11551
| CAS No. | CATO-C4X-11551 |
| Molecular Formula | C19H19F2N3O4 |
| Molecular Weight | 391.37 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
The occurrence of Sitafloxacin Impurity 1 is closely related to a flavonoid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.
As a process- or degradation-related impurity, Sitafloxacin Impurity 1 (CAS CATO-C4X-11551, C19H19F2N3O4) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
The molecular framework of Sitafloxacin Impurity 1 (C19H19F2N3O4) 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.
As a certified reference material (CRM), Sitafloxacin Impurity 1 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 | C19H19F2N3O4 |
| Molecular Weight | 391.37 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) | 11.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | F-containing |
| Nitrogen Atoms | 3 |
Related Sitafloxacin Standards
- Sitafloxacin Impurity 69 (CAS CATO-C4X-115569)
- Sitafloxacin Impurity 87 (CAS 500295-84-1)
- Sitafloxacin Impurity 29 (CAS CATO-C4X-115529)
- Sitafloxacin Dechloro Impurity (CAS CATO-C4X-115524)
- Sitafloxacin impurity 86 (CAS CATO-C4X-115586)
- Sitafloxacin Isomer Impurity 3(SSR) (CAS 127254-11-9)
- Sitafloxacin Isomer Impurity 4(RSR) (CAS 127199-06-8)
- Sitafloxacin Isomer Impurity (RRR) (CAS CATO-C4X-11555)
Recommended Standards
- TPA-023B, >98% (HPLC) (CAS 425377-76-0)
- Glycoperine (CAS 55740-45-9)
- 8-[4-Methoxy-3-(prop-2-yn-1-yloxy)phenyl]-5,12,14-trioxa-2-azatetracyclo[7.7.0.0^{3,7}.0^{11,15}]hexadeca-1(9),3(7),10,15-tetraen-6-one (CAS 900018-70-4)
- 1-((5-Cyclopentyl-1,2,4-oxadiazol-3-yl)methyl)-5-(3-(pyrazin-2-yl)-1,2,4-oxadiazol-5-yl)pyridin-2(1H)-one (CAS 1396855-78-9)
- Pimavanserin Impurity 52 (CAS CATO-C4X-193852)
- Limaprost Impurity 10 (CAS CATO-C4X-214510)
- Nebivolol Impurity 70 (CAS CATO-C4X-196870)
- N,N,1-Trimethylhydrazine-1-carbothioamide (CAS 2652-62-2)
- 2-(3,4-Dichlorophenyl)pyrimidine (CAS 1361566-43-9)
- (E)-1-(2,4-dichlorophenyl)-2-(1H-imidazol-1-yl)-ethanone O-[(2,4-dichlorophenyl)methyl]oxime mononitrate (CAS 64211-44-5)
- LCL 161 (CAS 1005342-46-0)
- 2,3-Dimethyl-3,5-diphenyl-2,3-dihydroisoxazole (CAS 62772-79-6)
- 1-(3-Methylphenyl)cyclopropane-1-carbonitrile (CAS 124276-71-7)
- Tirzepatide Impurity 38 (CAS CATO-C4X-324038)
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