Amoxicillin Impurity 50 CAS 127369-30-6
| CAS No. | 127369-30-6 |
| Molecular Formula | C9H11NO3 |
| Molecular Weight | N/A |
| 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 Amoxicillin Impurity 50.
CATO supplies Amoxicillin Impurity 50 (CAS 127369-30-6), a pharmacopoeial impurity reference standard (molecular formula C9H11NO3HCl, MW 217.65 g/mol) used for the identification and quantification of trace impurities in APIs.
The molecular framework of Amoxicillin Impurity 50 (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. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).
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 | 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.) | 1993 |
| 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 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)
- Amoxicillin EP Impurity D (CAS 1642629-94-4)
Recommended Standards
- Dalbavancin Impurity 9 (CAS CATO-C4X-16029)
- Nerandomilast impurity 29 (CAS CATO-C4X-347329)
- Mesna impurity 8 (CAS 74304-26-0)
- Tiotropium Impurity 26 (CAS 10299-90-8)
- Beclometasone Dipropionate Monohydrate (CAS 77011-63-3)
- N-(5-(2,3-Dihydrobenzo[b][1,4]dioxin-6-yl)-1,3,4-oxadiazol-2-yl)thiophene-2-carboxamide (CAS 851094-50-3)
- (s)-3-Amino-3-(1-methyl-1h-imidazol-5-yl)propanoic acid (CAS 1568221-37-3)
- 4-(4-Propoxybenzyl)-4,5-dihydrobenzo[f][1,4]oxazepin-3(2H)-one (CAS 1326882-95-4)
- (S)-Benzyl 2-carbamoyl-2-methylpyrrolidine-1-carboxylate (CAS 1031890-09-1)
- Liraglutide Impurity 30 (CAS CATO-C4X-199230)
Why CATO?
- ISO 17034 accredited reference material producer (CNAS + ANAB dual accreditation)
- 130,000+ catalog items in stock, COA supplied with every batch
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- Technical support: +86 18665070610 / Nicole.chen@cato-chem.com