Neratinib Impurity 14 CAS 1144516-14-2
| CAS No. | 1144516-14-2 |
| Molecular Formula | C26H21ClN6O4 |
| Molecular Weight | 516.94 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 Neratinib Impurity 14.
As a process- or degradation-related impurity, Neratinib Impurity 14 (CAS 1144516-14-2, C26H21ClN6O4) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Structurally, Neratinib Impurity 14 (C26H21ClN6O4) contains a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 19.0, corresponding to approximately 19 ring(s) or double-bond equivalent(s). With a molecular weight of 516.94 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 | C26H21ClN6O4 |
| Molecular Weight | 516.94 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor) |
| 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; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 19.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1989 |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 6 |
Related Neratinib Standards
- Neratinib Impurity 10 (CAS 1144516-13-1)
- Neratinib Impurity 62 (CAS CATO-C4X-113462)
- Neratinib Impurity 54 (CAS CATO-C4X-113454)
- Neratinib Impurity 13 (CAS 1144516-21-1)
- Neratinib Impurity 21 (CAS 1144516-15-3)
- Neratinib Impurity 5 (CAS CATO-C4X-11345)
- Neratinib Impurity 7 (CAS 915788-27-1)
- Neratinib Impurity 17 (CAS 1144516-19-7)
Recommended Standards
- (2Z)-3-[4-(2-{4-[3-chloro-5-(trifluoromethyl)pyridin-2-yl]piperazin-1-yl}ethoxy)phenyl]-1-(pyridin-4-yl)prop-2-en-1-one (CAS 338406-46-5)
- (3aR,4R,5R,6aS)-4-((E)-4-(3-Chlorophenoxy)-3-oxobut-1-en-1-yl)-2-oxohexahydro-2H-cyclopenta[b]furan-5-yl [1,1'-biphenyl]-4-carboxylate (CAS 54324-79-7)
- (3β)-3-O-tert-Butyldimethylsilyl-cholest-5-ene-3,24-diol (CAS 84529-86-2)
- BMS-856 (CAS 863382-83-6)
- Vildagliptin Impurity 99 (CAS CATO-C4X-110099)
- Faropenem Impurity 62 (CAS CATO-C4X-128962)
- Asenapine Impurity 6 (CAS 1847487-56-2)
- 2-(4-chlorophenyl)butan-1-amine (CAS 1004282-38-5)
- Methyl 2-chloro-4-(3,4-difluorophenyl)benzoate (CAS 1820734-40-4)
- (1H-imidazo[4,5-b]pyridin-2-yl)methanamine oxalate (CAS 1955520-17-8)
- 1,2,4,5-Tetrabromo-3,6-diisopropoxybenzene (CAS 120231-45-0)
- 4-methyl-2-(piperidin-1-ylmethyl)phenol (CAS 21236-74-8)
- 2-Chloro-N-methyl-N-((1-methylpiperidin-4-yl)methyl)acetamide (CAS 1341444-30-1)
- Semaglutide impurity 01 (CAS 1998701-31-7)
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