Ketoconazole EP Impurity C (and enantiomer) CAS 83374-59-8
| CAS No. | 83374-59-8 |
| Molecular Formula | C26H28Cl2N4O4 |
| Molecular Weight | 531.43 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Compared with other compounds in its class, the molecular weight of 531.43 g/mol gives Ketoconazole EP Impurity C (and enantiomer) distinctive chromatographic separation conditions and mass-spectrometry parameter settings.
Ketoconazole EP Impurity C (and enantiomer) (CAS 83374-59-8) is a certified pharmaceutical impurity reference standard with the molecular formula C26H28Cl2N4O4 and a molecular weight of 531.43 g/mol.
Based on its molecular formula C26H28Cl2N4O4, Ketoconazole EP Impurity C (and enantiomer) contains a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 531.43 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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.
As a certified reference material (CRM), Ketoconazole EP Impurity C (and enantiomer) 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 | C26H28Cl2N4O4 |
| Molecular Weight | 531.43 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor, low volatility) |
| Purity | >95% |
| Storage | Store in a cool place (≤25°C), protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in DMSO, DMF, methanol |
| 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) | 14.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1980 |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 4 |
Related Ketoconazole Standards
- Ketoconazole (CAS 65277-42-1)
- Ketoconazole Impurity 26 (CAS CATO-C4X-147226)
- Ketoconazole EP Impurity A (and enantiomer) (CAS 254912-63-5)
- Ketoconazole-d8 (CAS 1217706-96-1)
- Ketoconazole impurity 33 (CAS CATO-C4X-147233)
- Ketoconazole impurity 27 (CAS CATO-C4X-147227)
- Ketoconazole N-Oxide (and enantiomer) (CAS 254912-65-7)
- Ketoconazole N-Oxide (CAS 1392277-16-5)
Recommended Standards
- tert-butyl 4-(2-iodo-1-(2-phenyl-1H-benzo[d]imidazol-1-yl)ethyl)piperidine-1-carboxylate (CAS 2444540-38-7)
- 2-({5-[3-(2,4-dichlorophenoxy)propyl]-4-phenyl-4H-1,2,4-triazol-3-yl}sulfanyl)-N-(4-fluorophenyl)acetamide (CAS 882749-73-7)
- Levofolinate Impurity 18 (CAS CATO-C4X-133518)
- 1-(4-(4-((2-((1H-imidazol-1-yl)methyl)-2-(2,4-dichlorophenyl)-1,3-dioxolan-4-yl)methoxy)phenyl)piperazin-1-yl)ethan-1-one (CAS 79156-75-5)
- Tetrabenazine Impurity 26-D9 (CAS CATO-C4X-274826)
- 2,4-Dichlorobenzyl Alcohol EP Impurity A (CAS 34145-05-6)
- Maribavir Impurity 14 (CAS 142356-76-1)
- Warfarin Impurity 12 (CAS CATO-C4X-142912)
- n-Ethyl-4-methoxy-3-methylbenzenesulfonamide (CAS 664317-88-8)
- tert-Butyl 2-(1-Methylhydrazinyl)acetate (CAS 144036-71-5)
- Methyl 3-hydroxy-5-isopropoxybenzoate (CAS 480465-09-6)
- N-(2-Cyano-3-methylbutan-2-yl)-2-((5-(m-tolyl)-4-(p-tolyl)-4H-1,2,4-triazol-3-yl)thio)acetamide (CAS 763089-03-8)
- 2-(1-((((9H-fluoren-9-yl)methoxy)carbonyl)amino)-3-fluorocyclobutyl)acetic acid (CAS 2386763-40-0)
- Tirzepatide Impurity 61 (CAS CATO-C4X-324061)
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