Amoxicillin Impurity 49 CAS 57591-61-4
| CAS No. | 57591-61-4 |
| Molecular Formula | C9H11NO3 |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
As a certified reference material (CRM), Amoxicillin Impurity 49 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.
As a process- or degradation-related impurity, Amoxicillin Impurity 49 (CAS 57591-61-4, C9H11NO3HCl) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
The molecular framework of Amoxicillin Impurity 49 (C9H11NO3HCl) is characterized by a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, 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.
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.
Physical & Chemical Properties
| Molecular Formula | C9H11NO3 HCl |
| Molecular Weight | 217.65 g/mol |
| Appearance | Off-white to pale yellow crystalline powder. (slight halide-like odor, faint amine-like odor) |
| Purity | >95% |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry, keep tightly closed to prevent evaporation |
| Solubility (reference) | Soluble in methanol, ethanol, DMSO |
| 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) | 4.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1973 |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 1 |
Related Amoxicillin Standards
- rac-Amoxicillin EP Impurity H (CAS 106644-43-3)
- Amoxicillin EP impurity D2-2 (CAS 107437-40-1)
- Amoxicillin EP Impurity F (CAS 126247-63-0)
- Amoxicillin Impurity 50 (CAS 127369-30-6)
- Amoxicillin Impurity 17 (CAS 1313237-94-3)
- Amoxicillin EP Impurity E (CAS 1356020-01-3)
- Amoxicillin-13C2,15N (Mixture of Diastereomers) (CAS 1357002-99-3)
- Amoxicillin EP Impurity D Na (CAS 1642559-71-4)
Recommended Standards
- Apalutamide Impurity 94 (CAS CATO-C4X-274994)
- Ivabradine impurity 84 (CAS 869856-10-0)
- Donepezil impurity 70 (CAS CATO-C4X-103970)
- N-allyl-2,2-dichloro-N-(3-(trifluoromethyl)phenyl)acetamide (CAS 61219-95-2)
- 1-((2-Methoxy-5-methylphenyl)sulfonyl)-1,2,5,6-tetrahydropyridine-3-carboxylic acid (CAS 1373247-60-9)
- Ethyl 8-(2-chloropyridin-3-yl)-8-oxooctanoate (CAS 890100-61-5)
- 2-(2-Methyl-4-(methylsulfonyl)phenoxy)acetic acid (CAS 1368137-95-4)
- n-[(2,4,6-trimethylphenyl)methyl]cyclopentanamine (CAS 1019579-67-9)
- Terbucarb (CAS 1918-11-2)
- Semaglutide Impurity 4 (CAS CATO-C4X-22264)
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