Dabrafenib Impurity N2 CAS 1195767-77-1
| CAS No. | 1195767-77-1 |
| Molecular Formula | C23H20F3N5O3S2 |
| Molecular Weight | 535.56 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
As a process- or degradation-related impurity, Dabrafenib Impurity N2 (CAS 1195767-77-1, C23H20F3N5O3S2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Structurally, Dabrafenib Impurity N2 (C23H20F3N5O3S2) contains a steroid core, an amide group, a sulfone group, a hydroxyl group, an ether linkage, fluorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 15.0, corresponding to approximately 15 ring(s) or double-bond equivalent(s). With a molecular weight of 535.56 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 | C23H20F3N5O3S2 |
| Molecular Weight | 535.56 g/mol |
| 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) | 15.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1989 |
| Halogen Content | F-containing |
| Nitrogen Atoms | 5 |
| Sulfur Atoms | 2 |
Related Dabrafenib Standards
- Dabrafenib Impurity 37 (CAS CATO-C4X-303337)
- Dabrafenib Impurity 38 (CAS 3052138-43-6)
- Dabrafenib Impurity 9 (CAS CATO-C4X-30339)
- Dabrafenib Impurity 19 (CAS 1907654-22-1)
- Dabrafenib Impurity N7 (CAS 1195768-23-0)
- Dabrafenib Impurity 12 (CAS CATO-C4X-303312)
- Dabrafenib-D9 (CAS 1423119-98-5)
- Dabrafenib Impurity 36 (CAS CATO-C4X-303336)
Recommended Standards
- Sotorasib impurity 1 (CAS CATO-C4X-31031)
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- Metronidazole Impurity 25 (CAS 16156-93-7)
- Dopamine Impurity 94 (CAS CATO-C4X-190894)
- Alanyl Glutamine Impurity 22 TFA Salt (CAS 1115-78-2)
- 3-tert-Butyl-4,5-dihydro-1,2-oxazole-5-carboxylic acid (CAS 1601085-89-5)
- 3-Amino-2-methyl-1-(4-methylcyclohexyl)propan-1-ol (CAS 1522019-84-6)
- 4-Chloro-6-nitroquinazoline hydrochloride (CAS 220488-24-4)
- 1,3-Dichloro-2-propanol-d5 (CAS 1173020-20-6)
- 2-(3-Hydroxyisoxazol-5-yl)acetic acid (CAS 54489-27-9)
- 4-Iodo-1H-imidazole-2-carboxylic acid (CAS 1824286-45-4)
- Tirzepatide Impurity 13 (CAS CATO-C4X-324013)
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