Acalabrutinib Impurity 21 CAS 2412166-56-2
| CAS No. | 2412166-56-2 |
| Molecular Formula | C30H25N7O3 |
| Molecular Weight | 531.56 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
As a process- or degradation-related impurity, Acalabrutinib Impurity 21 (CAS 2412166-56-2, C30H25N7O3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Acalabrutinib Impurity 21 (C30H25N7O3) contains a steroid core, an amide group, a hydroxyl group, an ether linkage. It is notably hygroscopic, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).
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 | C30H25N7O3 |
| Molecular Weight | 531.56 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) | 22.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 2000 |
| Nitrogen Atoms | 7 |
Related Acalabrutinib Standards
- Acalabrutinib Impurity 1 (CAS CATO-C4X-30551)
- Acalabrutinib-D4 (CAS 1420477-60-6(Unlabelled))
- Acalabrutinib Impurity 22 (CAS CATO-C4X-305522)
- Acalabrutinib Impurity N1 (CAS 1952316-43-6)
- Acalabrutinib (CAS 1420477-60-6)
- Acalabrutinib Impurity 18 (CAS CATO-C4X-305518)
- Acalabrutinib Impurity 19 (CAS CATO-C4X-305519)
- Acalabrutinib Impurity 23 (CAS CATO-C4X-305523)
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