Pefloxacin Mesilate Dihydrate EP Impurity B CAS 70458-73-0
| CAS No. | 70458-73-0 |
| Molecular Formula | C17H20ClN3O3 |
| Molecular Weight | 349.81 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Based on its molecular formula C17H20ClN3O3, Pefloxacin Mesilate Dihydrate EP Impurity B contains a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 349.81 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.
As a process- or degradation-related impurity, Pefloxacin Mesilate Dihydrate EP Impurity B (CAS 70458-73-0, C17H20ClN3O3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
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 | C17H20ClN3O3 |
| Molecular Weight | 349.81 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.) | 1977 |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 3 |
Related Pefloxacin Standards
- Pefloxacin Mesilate Dihydrate EP Impurity D (CAS 85145-21-7)
- Pefloxacin-D5 (CAS 1228182-51-1)
- Pefloxacin Impurity 1 (CAS 81530-83-8)
- Pefloxacin Impurity 7 (CAS CATO-C4X-23337)
- Pefloxacin Impurity 8 (CAS CATO-C4X-23338)
- Pefloxacin Impurity 9 (CAS 125292-94-6)
- Pefloxacin Mesilate Dihydrate EP Impurity G (CAS 70458-94-5)
- Pefloxacin Impurity 2 (CAS CATO-C4X-23332)
Recommended Standards
- Felodipine Impurity 32 (CAS CATO-C4X-109432)
- Amlodipine Impurity N22 (CAS 39562-06-6)
- N-(4-Chlorophenyl)-2-(8-methyl-2,4-dioxo-1,3-diazaspiro[4.5]decan-3-yl)acetamide (CAS 785706-83-4)
- 9-Benzyl-2-chloro-N-(p-tolyl)-9H-purin-6-amine (CAS 125802-49-5)
- Idebenone Impurity N2 (CAS 77712-29-9)
- Brivaracetam impurity 96 (CAS 164453-64-9)
- Orlistat Dihydropyranone Impurity (CAS 130676-64-1)
- n-(4-Fluorophenyl)-5-methyl-3-phenylisoxazole-4-carboxamide (CAS 505088-42-6)
- 7-Chloro-4-(piperazin-1-yl)quinoline (CAS 837-52-5)
- (4-Cyclopropylphenyl)methanamine (CAS 118184-67-1)
- Ethyl 5-benzyl-4-oxo-4,5-dihydro-3H-pyrrolo[3,2-d]pyrimidine-7-carboxylate (CAS 1318133-16-2)
- Rivaroxaban Impurity 178 (CAS CATO-C4X-1090178)
- 3-(Aminomethyl)-4-chloropyridin-2-amine hydrochloride (CAS 1447606-43-0)
- Peptide 431 (CAS CATO-CPTD788431)
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