Osimertinib Impurity 88 CAS CATO-C4X-204588
| CAS No. | CATO-C4X-204588 |
| Molecular Formula | C25H29N7O3 |
| Molecular Weight | 475.54 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Osimertinib Impurity 88 (CAS CATO-C4X-204588) is a certified pharmaceutical impurity reference standard with the molecular formula C25H29N7O3 and a molecular weight of 475.54 g/mol.
The molecular framework of Osimertinib Impurity 88 (C25H29N7O3) is characterized by a steroid core, an amide group, a hydroxyl group, an ether linkage. 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 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 | C25H29N7O3 |
| Molecular Weight | 475.54 g/mol |
| Appearance | Pale yellow to yellow crystalline powder |
| 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 |
| Degree of Unsaturation (DBE) | 15.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Nitrogen Atoms | 7 |
Related Osimertinib Standards
- Osimertinib Impurity N1 (CAS 1421372-67-9)
- Osimertinib Impurity 101 (CAS CATO-C4X-2045101)
- Osimertinib Impurity 18 (CAS CATO-C4X-204518)
- Osimertinib Impurity N3 (CAS 1421373-99-0)
- Osimertinib Impurity 10 (CAS 1421373-98-9)
- Osimertinib Impurity 30 (CAS CATO-C4X-204530)
- Osimertinib Impurity 92 (CAS CATO-C4X-204592)
- Osimertinib Impurity 41 (CAS CATO-C4X-204541)
Recommended Standards
- Palbociclib Impurity 57 (CAS 2174002-16-3)
- N-Nitroso Dalpiciclib impurity 2 (CAS CATO-C4X-32952)
- Palbociclib Impurity 135 (CAS CATO-C4X-1125135)
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- Tolvaptan Impurity 14 (CAS 137973-76-3)
- Ibrutinib Impurity 109 (CAS 2803461-05-2)
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- 3-(4-Ethylphenyl)-3-methylbutanoic acid (CAS 132858-67-4)
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- 3-Amino-N-(2,4-dimethoxyphenyl)-6-ethyl-5,6,7,8-tetrahydrothieno[2,3-b]quinoline-2-carboxamide (CAS 445269-12-5)
- 5-((Dimethylamino)methyl)isoxazole-3-carbaldehyde (CAS 893749-69-4)
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