Crisaborole Impurity 65 CAS 1217366-74-9
| CAS No. | 1217366-74-9 |
| Molecular Formula | C16H12BrNO3 |
| Molecular Weight | 346.18 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
As a process- or degradation-related impurity, Crisaborole Impurity 65 (CAS 1217366-74-9, C16H12BrNO3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Structurally, Crisaborole Impurity 65 (C16H12BrNO3) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, bromine substitution. The molecule exhibits a degree of unsaturation (DBE) of 11.0, corresponding to approximately 11 ring(s) or double-bond equivalent(s). With a molecular weight of 346.18 g/mol, it falls into the moderately-high-molecular-weight range. 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 | C16H12BrNO3 |
| Molecular Weight | 346.18 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.) | 1990 |
| Halogen Content | Br-containing |
| Nitrogen Atoms | 1 |
Related Crisaborole Standards
- Crisaborole lmpurity 100 (CAS CATO-C4X-2021100)
- Crisaborole lmpurity 101 (CAS CATO-C4X-2021101)
- Crisaborole impurity 105 (CAS CATO-C4X-2021105)
- Crisaborole impurity 108 (CAS CATO-C4X-2021108)
- Crisaborole impurity 113 (CAS CATO-C4X-2021113)
- Crisaborole impurity 156 (CAS CATO-C4X-2021156)
- Crisaborole lmpurity 76 (CAS 2227126-09-0)
- Crisaborole impurity 129 (CAS CATO-C4X-2021129)
Recommended Standards
- (1'-(tert-Butoxycarbonyl)-2-oxospiro[indoline-3,4'-piperidin]-5-yl)boronic acid (CAS 1246372-96-2)
- N-(2-Bromo-4-fluorophenyl)-O-(tert-butoxycarbonyl)-N-cyclopropylhydroxylamine (CAS 1704073-63-1)
- 2-((4-Amino-5-oxo-4,5-dihydro-1,2,4-triazin-3-yl)thio)-N-(3,4-dichlorophenyl)acetamide (CAS 898622-16-7)
- 2-((4-Amino-5-oxo-4,5-dihydro-1,2,4-triazin-3-yl)thio)-N-(3,5-dichlorophenyl)acetamide (CAS 898622-18-9)
- Mupirocin EP Impurity D Sodium Salt (CAS 116182-43-5)
- Suvorexant Impurity 35 (CAS CATO-C4X-181235)
- Itraconazole Impurity 33 (CAS CATO-C4X-149733)
- Diethyldithiocarbamic acid benzyl ester (CAS 3052-61-7)
- Piperidin-4-amine dihydrochloride (CAS 35621-01-3)
- 4-Isopropyl-5-methylpyrimidin-2-amine (CAS 35733-55-2)
- 3-ethynyl-3-hydroxy-1-methylpyrrolidin-2-one (CAS 1202769-93-4)
- 2-(6-chloro-3-pyridinyl)-2-(phenylsulfonyl)acetaldehyde O-methyloxime (CAS 478048-56-5)
- (S)-2-(((tert-butyldiphenylsilyl)oxy)methyl)cyclobutan-1-one (CAS 135253-29-1)
- 263251-78-1 NMG938VJ6T D-3 Tavilermide [USAN:INN] UNII-NMG938VJ6T MIM-D3 MIM-D 3 D 3 (peptide) Tavilermide (CAS 263251-78-1)
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