Alectinib Impurity 11 CAS 1256698-41-5
| CAS No. | 1256698-41-5 |
| Molecular Formula | C34H44N4O3 |
| Molecular Weight | 556.74 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Alectinib Impurity 11 (CAS 1256698-41-5) is a certified pharmaceutical impurity reference standard with the molecular formula C34H44N4O3 and a molecular weight of 556.74 g/mol.
The molecular framework of Alectinib Impurity 11 (C34H44N4O3) is characterized by a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, 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.
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.
Physical & Chemical Properties
| Molecular Formula | C34H44N4O3 |
| Molecular Weight | 556.74 g/mol |
| Appearance | Pale yellow to yellow crystalline powder |
| 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 |
| Degree of Unsaturation (DBE) | 15.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1990 |
| Nitrogen Atoms | 4 |
Related Alectinib Standards
- Alectinib impurity 29 (CAS 1256585-30-4)
- Alectinib impurity 20 (CAS 2287185-55-9)
- Alectinib Impurity 34 (CAS 2412921-45-8)
- Alectinib Impurity 41 (CAS CATO-C4X-283641)
- Alectinib Impurity 81 (CAS CATO-C4X-283681)
- Alectinib impurity 26 (CAS CATO-C4X-283626)
- Alectinib Impurity 47 (CAS CATO-C4X-283647)
- Alectinib Impurity 64 (CAS CATO-C4X-283664)
Recommended Standards
- 9,9-Dimethyl-N,N'-bis(3-methylphenyl)-N,N'-diphenyl-9H-fluorene-2,7-diamine (CAS 677350-83-3)
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- Deloxolone (CAS 68635-50-7)
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