Mexiletine Impurity 3 CAS 123363-66-6
| CAS No. | 123363-66-6 |
| Molecular Formula | C11H17NO2 |
| 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 Mexiletine Impurity 3.
As a process- or degradation-related impurity, Mexiletine Impurity 3 (CAS 123363-66-6, C11H17NO2HCl) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
The molecular framework of Mexiletine Impurity 3 (C11H17NO2HCl) is characterized by an amide group, a carboxylic acid 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. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.
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), Mexiletine Impurity 3 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 | C11H17NO2 HCl |
| Molecular Weight | 231.72 g/mol |
| Appearance | White to pale yellow crystalline powder. (slight halide-like odor) |
| Purity | 97%+ |
| Storage | Store at 2-8°C, protect from light, keep tightly closed to prevent evaporation |
| Solubility (reference) | Soluble in chloroform, dichloromethane, ethyl acetate, DMSO |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 3.0 |
| UV Absorption | UV-absorbing |
| CAS Registry Year (est.) | 1992 |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 1 |
Related Mexiletine Standards
- Mexiletine Impurity N4 (CAS 1051392-53-0)
- Mexiletine Impurity N5 (CAS 117322-90-4)
- Mexiletine impurity N1 (CAS 117322-92-6)
- Mexiletine-d6 Hydrochloride (CAS 1329835-60-0)
- Mexiletine Impurity 13 HCl (CAS 149961-12-6)
- Mexiletine Impurity N3 (CAS 180966-61-4)
- Mexiletine EP Impurity C (CAS 2059988-38-2)
- Mexiletine EP Impurity C DiHCl (CAS 2059988-39-3)
Recommended Standards
- Nimodipine Impurity 20 (CAS CATO-C4X-138520)
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- Oleanolic Acid Impurity 1 (CAS 35738-25-1)
- 5-bromo-6-iodo-7-methyl-pyrrolo[2,3-d]pyrimidin-4-amine (CAS 2549186-23-2)
- tert-Butyl 2-(((3-cyanopyridin-2-yl)thio)methyl)pyrrolidine-1-carboxylate (CAS 1353978-84-3)
- 2-(2-Isopropyl-5-methylphenoxy)-5-methylaniline (CAS 946728-50-3)
- 8-Hydroxydictanmnine (CAS 2255-50-7)
- Dimethyl4,4'-(9H-carbazole-3,6-diyl)dibenzoate (CAS 1258419-88-3)
- [14-31]-Semaglutide (CAS CATO-C4X-2226262)
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