Palbociclib Impurity 8 CAS CATO-C4X-11258
| CAS No. | CATO-C4X-11258 |
| Molecular Formula | C18H17Br2N5O |
| Molecular Weight | 479.17 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Palbociclib Impurity 8.
As a process- or degradation-related impurity, Palbociclib Impurity 8 (CAS CATO-C4X-11258, C18H17Br2N5O) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Structurally, Palbociclib Impurity 8 (C18H17Br2N5O) contains a steroid core, an amide group, a hydroxyl group, an ether linkage, bromine substitution. The molecule exhibits a degree of unsaturation (DBE) of 12.0, corresponding to approximately 12 ring(s) or double-bond equivalent(s). With a molecular weight of 479.17 g/mol, it falls into the moderately-high-molecular-weight range. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.
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 | C18H17Br2N5O |
| Molecular Weight | 479.17 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor, low volatility) |
| Purity | 97%+ |
| Storage | Store at room temperature, protect from light |
| Solubility (reference) | Soluble in DMSO, DMF, methanol |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light |
| Degree of Unsaturation (DBE) | 12.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | Br-containing |
| Nitrogen Atoms | 5 |
Related Palbociclib Standards
- Palbociclib Impurity 154 (CAS CATO-C4X-1125154)
- Palbociclib Impurity 125 (CAS CATO-C4X-1125125)
- Palbociclib impurity 128 (CAS CATO-C4X-1125128)
- Palbociclib impurity 130 (CAS CATO-C4X-1125130)
- Palbociclib Impurity 146 (CAS 2955712-44-2)
- Palbociclib Impurity 121 (CAS 1974279-40-7)
- Palbociclib Impurity 135 (CAS CATO-C4X-1125135)
- Palbociclib Impurity 57 (CAS 2174002-16-3)
Recommended Standards
- 4-(2-Amino-6-oxo-1H-purin-9(6H)-yl)-2-hydroxybutyl tetrahydrogen triphosphate (CAS 108491-46-9)
- 1023537-45-2 2-(3-bromophenyl)-1-(3,5-dichloro-4-hydroxyphenyl)-6,6-dimethyl-4,5,6,7-tetrahydro-1H-indol-4-one MS-10295 (CAS 1023537-45-2)
- Lifitegrast Impurity 158 (CAS CATO-C4X-2409158)
- Isopropyl 2,7-dibromospiro[fluorene-9,4'-piperidine]-1'-carboxylate (CAS 1804963-67-4)
- Faropenem Impurity 75 (CAS CATO-C4X-128975)
- Semaglutide impurity 270 (CAS CATO-C4X-2226270)
- Cytarabine EP Impurity I (CAS 6829-31-8)
- N-methyl-1-(1-(tetrahydro-2H-pyran-4-yl)-1H-pyrazol-4-yl)methanamine (CAS 1343430-57-8)
- 1-(4-Bromophenyl)-1h-imidazol-2-amine (CAS 1698717-00-8)
- 2-Bromo-6-(tert-butyl)-3-cyclopropoxypyridine (CAS 1243355-24-9)
- 2-(4-Bromophenyl)-1H-imidazo[4,5-c]pyridine (CAS 113270-73-8)
- 2-Adamantanone (CAS 700-58-3)
- 4-Chloro-2-(N-phenylsulfamoyl)benzoic acid, 97% (CAS 887587-31-7)
- Neuropeptide Y (free acid) (human, rat) trifluoroacetate salt (CAS 99575-89-0)
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