Ketoconazole Impurity 10 CAS 70894-66-5
| CAS No. | 70894-66-5 |
| Molecular Formula | C21H18Cl2N2O4 |
| Molecular Weight | 433.28 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
As a certified reference material (CRM), Ketoconazole Impurity 10 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.
Ketoconazole Impurity 10 (CAS 70894-66-5) is a certified pharmaceutical impurity reference standard with the molecular formula C21H18Cl2N2O4 and a molecular weight of 433.28 g/mol.
Owing to a flavonoid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution, Ketoconazole Impurity 10 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 433.28 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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.
Physical & Chemical Properties
| Molecular Formula | C21H18Cl2N2O4 |
| Molecular Weight | 433.28 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor, low volatility) |
| Purity | 97%+ |
| 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) | 13.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1977 |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 2 |
Related Ketoconazole Standards
- Ketoconazole impurity 30 (CAS CATO-C4X-147230)
- Ketoconazole impurity 34 (CAS CATO-C4X-147234)
- Ketoconazole Impurity 36 (CAS CATO-C4X-147236)
- Ketoconazole Impurity 6 (CAS 61397-56-6)
- Ketoconazole Impurity 9 (CAS 331949-30-5)
- Ketoconazole Impurity 14 (CAS 170210-50-1)
- Ketoconazole EP Impurity E (CAS 134071-44-6)
- Ketoconazole impurity 32 (CAS CATO-C4X-147232)
Recommended Standards
- N,N-Bis-boc-2-iodo-6-methyl-phenylamine (CAS 2055840-80-5)
- Methyl 3-(2-{[(4-bromophenyl)carbamoyl]carbonyl}-1H-pyrrol-1-yl)thiophene-2-carboxylate (CAS 477857-81-1)
- Oxaliplatin Impurity 4 (CAS CATO-C4X-27614)
- Defluoro Hydroxy AM-694 (CAS 335160-94-6)
- Phenacetin Impurity 2 (CAS 65570-13-0)
- Celecoxib Impurity 48 (CAS 921617-76-7)
- Tegoprazan Impurity 69 (CAS CATO-C4X-229769)
- 6-Chloro-2-(2-propoxyphenyl)quinoline-4-carboxylic acid (CAS 932929-02-7)
- Methyl (5-(pyrazin-2-ylthio)-1H-benzo[d]imidazol-2-yl)carbamate (CAS 55564-31-3)
- (1S,4R,6S)-1-Methyl-4-(prop-1-en-2-yl)-7-oxabicyclo[4.1.0]heptan-2-one (CAS 18383-49-8)
- 5-Methyl-7-(3-(trifluoromethyl)phenyl)-N-(3,4,5-trimethoxyphenyl)imidazo[5,1-f][1,2,4]triazin-2-amine (CAS 774460-98-9)
- 7-tert-Butyl-2-mercapto-3-(5-methoxy-2-methyl-phenyl)-5,6,7,8-tetrahydro-3H-benzo[4,5]thieno[2,3-d]pyrimidin-4-one (CAS 744242-01-1)
- (E)-N-(3,4-dichlorophenyl)-2-oxo-2-(2-(3,4,5-trimethoxybenzylidene)hydrazinyl)acetamide (CAS 765274-40-6)
- Semaglutide impurity 70 (CAS CATO-C4X-222670)
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