Ropivacaine EP Impurity A HCl CAS 27262-48-2
| CAS No. | 27262-48-2 |
| Molecular Formula | C18H28N2O |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
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.
Ropivacaine EP Impurity A HCl (CAS 27262-48-2) is a certified pharmaceutical impurity reference standard with the molecular formula C18H28N2OHCl and a molecular weight of 324.89 g/mol.
The molecular framework of Ropivacaine EP Impurity A HCl (C18H28N2OHCl) is characterized by a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. In reversed-phase chromatography, its retention is governed primarily by its high hydrophobicity (logP), 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 | C18H28N2O HCl |
| Molecular Weight | 324.89 g/mol |
| Appearance | Off-white to pale yellow crystalline powder. (slight halide-like odor) |
| Purity | >95% |
| Storage | Store at 2-8°C, protect from light |
| Solubility (reference) | Soluble in DMSO, DMF, methanol |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light |
| Degree of Unsaturation (DBE) | 5.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1964 |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 2 |
Related Ropivacaine Standards
- Ropivacaine EP Impurity E(R-Isomer) (CAS 1050482-18-2)
- Ropivacaine EP Impurity G HCI (CAS 112773-90-7)
- Ropivacaine-d7 Hydrochloride (CAS 1217667-10-1)
- Ropivacaine Hydrochloride Monohydrate (CAS 132112-35-7)
- Ropivacaine Impurity 9 (CAS 13388-86-8)
- Ropivacaine Impurity 16 (CAS 1391053-59-0)
- Ropivacaine Impurity 37 (CAS 1583238-33-8)
- Ropivacaine Impurity 34 (CAS 175888-75-2)
Recommended Standards
- Resmetirom impurity 94 (CAS CATO-C4X-291294)
- Bumetanide Impurity 76 (CAS CATO-C4X-198676)
- Cytidine Impurity 3 (CAS 54619-78-2)
- 3-Methyl-4-((tetrahydro-2H-pyran-4-yl)methoxy)aniline (CAS 1248905-71-6)
- 6-Bromo-3-methyl-3,4-dihydroquinolin-2(1H)-one (CAS 113092-92-5)
- 5-Amino-1-((3-bromothiophen-2-yl)methyl)pyridin-2(1h)-one (CAS 1250563-29-1)
- (E)-2-(4-Chloro-2-buten-1-yl)isoindoline-1,3-dione (CAS 49705-66-0)
- N1-(4-(1,1-Dioxido-1,2-thiazinan-2-yl)phenyl)-N2-methyloxalamide (CAS 899956-12-8)
- 1-Ethyl-1H-imidazole-4-carbaldehyde (CAS 88091-37-6)
- Semaglutide impurity 256 (CAS CATO-C4X-2226256)
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