Osimertinib Impurity N2 CAS 1421373-36-5 (free base)
| CAS No. | 1421373-36-5 (free base) |
| Molecular Formula | C28H34ClN7O2 |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
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.
As a process- or degradation-related impurity, Osimertinib Impurity N2 (CAS 1421373-36-5 (free base), C28H34ClN7O2HCl) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
The molecular framework of Osimertinib Impurity N2 (C28H34ClN7O2HCl) is characterized by a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).
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.
Physical & Chemical Properties
| Molecular Formula | C28H34ClN7O2 HCl |
| Molecular Weight | 572.53 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor, low volatility) |
| 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) | 14.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 7 |
Related Osimertinib Standards
- Osimertinib Impurity 5 (CAS 1009298-59-2)
- Osimertinib Impurity 8 (CAS 1421372-66-8)
- Osimertinib Impurity N1 (CAS 1421372-67-9)
- Osimertinib (CAS 1421373-65-0)
- Osimertinib Impurity 10 (CAS 1421373-98-9)
- Osimertinib Impurity N3 (CAS 1421373-99-0)
- Osimertinib-3 (CAS 1446700-26-0)
- Osimertinib D6 (CAS 1638281-44-3)
Recommended Standards
- Cyproheptadine Impurity 5 (CAS 54191-04-7)
- Meclofenoxate Impurity 10 (CAS 41944-93-8)
- Erlotinib Impurity 100 (CAS 950596-59-5)
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- 2-(2-Bromoethyl)-1-methyl-1h-imidazole (CAS 1343327-75-2)
- N-Boc-L-isoleucine Hemihydrate (CAS 204138-23-8)
- Methyl 3-Methylisoxazole-4-carboxylate (CAS 92234-50-9)
- 4-Allyl-2,5-dimethyl-1H-pyrazol-3(2H)-one (CAS 856847-41-1)
- 1-(5-Chloro-1-(3-methoxypropyl)-1H-benzo[d]imidazol-2-yl)ethan-1-one (CAS 1437435-18-1)
- Liraglutide Impurity 21 TFA Salt (CAS CATO-C4X-199221)
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