Norfloxacin EP Impurity H CAS 105440-01-5
| CAS No. | 105440-01-5 |
| Molecular Formula | C19H22FN3O5 |
| Molecular Weight | 391.39 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
As a process- or degradation-related impurity, Norfloxacin EP Impurity H (CAS 105440-01-5, C19H22FN3O5) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Based on its molecular formula C19H22FN3O5, Norfloxacin EP Impurity H contains a flavonoid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 391.39 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).
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), Norfloxacin EP Impurity H 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 | C19H22FN3O5 |
| Molecular Weight | 391.39 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor) |
| Purity | >95% |
| 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) | 10.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1987 |
| Halogen Content | F-containing |
| Nitrogen Atoms | 3 |
Related Norfloxacin Standards
- Norfloxacin Impurity 21 (CAS 103240-27-3)
- Norfloxacin Impurity 20 (CAS CATO-C4X-146820)
- Norfloxacin Impurity 62 (CAS CATO-C4X-146862)
- Norfloxacin Impurity 54 (CAS CATO-C4X-146854)
- Norfloxacin Impurity 55 (CAS CATO-C4X-146855)
- Norfloxacin Impurity 41 (CAS CATO-C4X-146841)
- Norfloxacin Impurity 51 (CAS CATO-C4X-146851)
- Norfloxacin Impurity 56 (CAS CATO-C4X-146856)
Recommended Standards
- Gatifloxacin Impurity 19 (CAS 1798008-43-1)
- 3-((((9H-Fluoren-9-yl)methoxy)carbonyl)amino)-2-sulfopropanoic acid (CAS 1005412-03-2)
- Gatifloxacin Impurity 10 (CAS 1335198-95-2)
- Methyl (2Z)-3-[(2H-1,3-benzodioxol-5-yl)amino]-2-(4-methoxybenzenesulfonyl)prop-2-enoate (CAS 1327171-84-5)
- Lercanidipine Impurity 55 (CAS CATO-C4X-136455)
- Aceclofenac Impurity 18 (CAS 2518198-70-2)
- Ensifentrine Impurity 3 (CAS 3067475-18-4)
- 2-Methyl-2-(trifluoromethyl)piperazine (CAS 1779765-53-5)
- 3-Bromo-6-chlorobenzene-1,2-diamine (CAS 1823876-88-5)
- tert-Butyl 2-aminopiperidine-1-carboxylate (CAS 885954-09-6)
- tert-Butyl 2-(2,5-dimethoxyphenyl)piperazine-1-carboxylate (CAS 886769-68-2)
- 3-(4,5-Dihydro-1H-imidazol-2-yl)isoquinoline hydrochloride (CAS 1186195-56-1)
- 3-amino-1-ethyl-1,2-dihydropyrazin-2-one (CAS 1343050-71-4)
- (Tyr?)-C-Type Natriuretic Peptide (32-53) (human, porcine, rat) (CAS 142878-79-3)
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