Crisaborole lmpurity 68 CAS 943311-78-2
| CAS No. | 943311-78-2 |
| Molecular Formula | C19H18BrNO3 |
| Molecular Weight | 388.26 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
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 process- or degradation-related impurity, Crisaborole lmpurity 68 (CAS 943311-78-2, C19H18BrNO3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Crisaborole lmpurity 68 (C19H18BrNO3) contains a steroid core, an amide group, a hydroxyl group, an ether linkage, bromine substitution. Halogen substitution raises its density and boiling point, its high carbon-to-hydrogen ratio confers good lipid solubility, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).
As a certified reference material (CRM), Crisaborole lmpurity 68 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 | C19H18BrNO3 |
| Molecular Weight | 388.26 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor) |
| Purity | >95% |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in chloroform, dichloromethane, ethyl acetate, DMSO |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 11.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1987 |
| Halogen Content | Br-containing |
| Nitrogen Atoms | 1 |
Related Crisaborole Standards
- Crisaborole Impurity 56 (CAS CATO-C4X-202156)
- Crisaborole impurity 119 (CAS CATO-C4X-2021119)
- Crisaborole Impurity 59 (CAS CATO-C4X-202159)
- Crisaborole impurity 106 (CAS CATO-C4X-2021106)
- Crisaborole impurity 107 (CAS CATO-C4X-2021107)
- Crisaborole impurity 114 (CAS CATO-C4X-2021114)
- Crisaborole impurity 122 (CAS CATO-C4X-2021122)
- Crisaborole Impurity 138 (CAS CATO-C4X-2021138)
Recommended Standards
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