| CAS No. | 1376615-55-2 |
| Molecular Formula | C30H29ClN6O4 |
| Molecular Weight | 573.04 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
The occurrence of Neratinib Impurity 15 is closely related to a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.
Neratinib Impurity 15 (CAS 1376615-55-2) is a certified pharmaceutical impurity reference standard with the molecular formula C30H29ClN6O4 and a molecular weight of 573.04 g/mol.
Structurally, Neratinib Impurity 15 (C30H29ClN6O4) 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 573.04 g/mol, it falls into the moderately-high-molecular-weight range. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.
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.
CATO manufactures Neratinib Impurity 15 under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.
| Molecular Formula | C30H29ClN6O4 |
| Molecular Weight | 573.04 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.) | 1991 |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 6 |