Ketoconazole Impurity 8 (Mixture of diastereomers) CAS 68751-57-5
| CAS No. | 68751-57-5 |
| Molecular Formula | C11H11BrCl2O3 |
| Molecular Weight | 342.01 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
CATO supplies Ketoconazole Impurity 8 (Mixture of diastereomers) (CAS 68751-57-5), a pharmacopoeial impurity reference standard (molecular formula C11H11BrCl2O3, MW 342.01 g/mol) used for the identification and quantification of trace impurities in APIs.
The molecular framework of Ketoconazole Impurity 8 (Mixture of diastereomers) (C11H11BrCl2O3) is characterized by a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine/bromine substitution, an aromatic ring system. 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 aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).
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 Impurity 8 (Mixture of diastereomers) 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 | C11H11BrCl2O3 |
| Molecular Weight | 342.01 g/mol |
| Appearance | Off-white to pale yellow crystalline powder. (slight halide-like odor, low volatility) |
| Purity | 97%+ |
| Storage | Store in a cool place (≤25°C), keep sealed and dry |
| Solubility (reference) | Soluble in methanol, ethanol, DMSO |
| Stability | May oxidize slowly on prolonged air exposure; Hygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 5.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1976 |
| Halogen Content | Cl/Br-containing |
Related Ketoconazole Standards
- Ketoconazole impurity 31 (CAS CATO-C4X-147231)
- Ketoconazole Impurity 38 (CAS 24123-68-0)
- Ketoconazole Impurity 20 (CAS CATO-C4X-147220)
- Ketoconazole Impurity 10 (CAS 61441-65-4)
- Ketoconazole Impurity 11 (CAS 84682-23-5)
- Ketoconazole Impurity 13 (and enantiomer) (CAS 61397-58-8)
- Ketoconazole Impurity 14 (CAS 170210-49-8)
- Ketoconazole Impurity 35 (CAS CATO-C4X-147235)
Recommended Standards
- 7-Bromo-5-chloro-2-(4-chlorophenyl)-1H-benzo[d]imidazole (CAS 16429-30-4)
- 7-Bromo-4,6-dichloro-8-fluoro-2-(methylthio)quinazoline (CAS 2757097-20-2)
- 5-Bromo-7-chloro-2-(4-chlorophenyl)-1H-benzo[d]imidazole (CAS 16429-36-0)
- 7-Bromo-2,6-dichloro-8-fluoro-4-(methylthio)quinazoline (CAS 2857929-87-2)
- Febantel Impurity 6 (CAS CATO-C4X-29065)
- Mivacurium chloride Impurity 58 (CAS CATO-C4X-137558)
- Esomeprazole Impurity 117 (CAS 1427498-68-7)
- 2-[5,7-Bis(trifluoromethyl)-1,8-naphthyridin-2-yl]-2-(4-chlorophenyl)acetonitrile (CAS 339104-13-1)
- Methyl 3,7-dibromoquinoline-2-carboxylate (CAS 1823865-17-3)
- Potassium Pentachlororuthenate(III) Hydrate (CAS 14404-33-2)
- 2-(2-Bromophenyl)-N-(2-phenylpropan-2-yl)acetamide (CAS 76440-32-9)
- 3-Butylphenol (CAS 4074-43-5)
- 5,6-Dimethylbenzofuran (CAS 24410-52-4)
- ([D?]Val?·1?)-C-Peptide (human) (CAS 1802078-41-6)
Why CATO?
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