| CAS No. | 64464-07-9 |
| Molecular Formula | C9H13NO2 |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Carvedilol Impurity 16.
Carvedilol Impurity 16 (CAS 64464-07-9) is a certified pharmaceutical impurity reference standard with the molecular formula C9H13NO2HCl and a molecular weight of 203.67 g/mol.
Owing to an amide group, a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution, Carvedilol Impurity 16 is typically white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 203.67 g/mol — guide the selection of appropriate sample preparation and analytical techniques. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.
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.
| Molecular Formula | C9H13NO2 HCl |
| Molecular Weight | 203.67 g/mol |
| Appearance | 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 tightly closed to prevent evaporation |
| Solubility (reference) | Soluble in methanol, acetonitrile, DMSO, water (slightly soluble) |
| 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.) | 1975 |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 1 |