| CAS No. | CATO-C4X-147220 |
| Molecular Formula | C14H9Cl3O3 |
| Molecular Weight | 331.58 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
The occurrence of Ketoconazole Impurity 20 is closely related to a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution, a polycyclic aromatic system in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.
CATO supplies Ketoconazole Impurity 20 (CAS CATO-C4X-147220), a pharmacopoeial impurity reference standard (molecular formula C14H9Cl3O3, MW 331.58 g/mol) used for the identification and quantification of trace impurities in APIs.
Owing to a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution, a polycyclic aromatic system, Ketoconazole Impurity 20 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 331.58 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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.
CATO manufactures Ketoconazole Impurity 20 under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.
| Molecular Formula | C14H9Cl3O3 |
| Molecular Weight | 331.58 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor, low volatility) |
| Purity | 97%+ |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in chloroform, dichloromethane, ethyl acetate, 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) | 9.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | Cl-containing |