Gatifloxacin Impurity 16 CAS 855997-06-7
| CAS No. | 855997-06-7 |
| Molecular Formula | C16H18FN3O4 |
| Molecular Weight | 335.33 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 Gatifloxacin Impurity 16.
Gatifloxacin Impurity 16 (CAS 855997-06-7) is a certified pharmaceutical impurity reference standard with the molecular formula C16H18FN3O4 and a molecular weight of 335.33 g/mol.
The molecular framework of Gatifloxacin Impurity 16 (C16H18FN3O4) 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. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.
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 | C16H18FN3O4 |
| Molecular Weight | 335.33 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor) |
| 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-containing |
| Nitrogen Atoms | 3 |
Related Gatifloxacin Standards
- Gatifloxacin Impurity 2 (CAS 172426-86-7)
- Gatifloxacin Impurity 26 (CAS 115685-58-0)
- Gatifloxacin Impurity 29 (CAS CATO-C4X-125329)
- Gatifloxacin Impurity 7 (CAS 172426-87-8)
- Gatifloxacin Related Compound D(3-Desmethyl Gatifloxacin) (CAS 112811-57-1)
- Gatifloxacin Impurity 3 (CAS 616205-76-6)
- Gatifloxacin Impurity 4 (CAS 103460-89-5)
- Gatifloxacin Impurity 18 (CAS 1048972-69-5)
Recommended Standards
- Moxifloxacin impurity 9 (CAS 2489671-14-7)
- N'-(4,6-Difluorobenzo[d]thiazol-2-yl)-2-phenoxyacetohydrazide (CAS 851988-51-7)
- Levofloxacin EP Impurity G(Levofloxacin USP Related Compound E) (CAS 151250-76-9)
- Methyl 4-[(4-methylphenyl)sulfonyl]-3-nitrobenzenecarboxylate (CAS 477871-40-2)
- Flunarizine impurity 50 (CAS CATO-C4X-135750)
- Rac-Levodopa EP Impurity A (CAS 21373-30-8)
- Nintedanib Impurity 109 (CAS CATO-C4X-1814109)
- 6-Methoxynaphthalene-2-thiol (CAS 83099-40-5)
- 1-(4-Piperidyl)piperazine (CAS 142013-66-9)
- Melphalan Impurity 31 (CAS CATO-C4X-198831)
- 2-Nitrotoluene-α,α,α-d3 (CAS 70786-67-3)
- Ethyl 9-(5-butyl-3-methylfuran-2-yl)nonanoate (CAS CATO-C4X-280632)
- 4-(bromomethyl)-2-methylbenzonitrile (CAS 1001055-64-6)
- Neuropeptide Y (13-36) (porcine) (CAS 113662-54-7)
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