| CAS No. | 1218-35-5 |
| Molecular Formula | C16H24N2 |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
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.
CATO supplies Oxymetazoline EP Impurity B HCl (CAS 1218-35-5), a pharmacopoeial impurity reference standard (molecular formula C16H24N2HCl, MW 280.84 g/mol) used for the identification and quantification of trace impurities in APIs.
The molecular framework of Oxymetazoline EP Impurity B HCl (C16H24N2HCl) is characterized by a nitrogen-containing heterocyclic scaffold, a nitrile group, 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.
As a certified reference material (CRM), Oxymetazoline EP Impurity B HCl 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.
| Molecular Formula | C16H24N2 HCl |
| Molecular Weight | 280.84 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, keep tightly closed to prevent evaporation |
| 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.) | 1957 |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 2 |