Irbesartan EP Impurity A CAS 748812-53-5
| CAS No. | 748812-53-5 |
| Molecular Formula | C25H30N6O2 |
| Molecular Weight | 446.54 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
The molecular framework of Irbesartan EP Impurity A (C25H30N6O2) 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).
As a process- or degradation-related impurity, Irbesartan EP Impurity A (CAS 748812-53-5, C25H30N6O2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
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 | C25H30N6O2 |
| Molecular Weight | 446.54 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) | 14.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1986 |
| Nitrogen Atoms | 6 |
Related Irbesartan Standards
- Irbesartan Impurity 4 (CAS CATO-C4X-16664)
- Irbesartan Impurity 13 (CAS CATO-C4X-166613)
- Irbesartan Impurity 34 (CAS CATO-C4X-166634)
- Irbesartan Impurity 20 (CAS 906474-58-6)
- Irbesartan-D9 (CAS 1242281-36-2)
- Irbesartan-d7 (CAS 1329496-43-6)
- Irbesartan Impurity 15 (CAS CATO-C4X-166615)
- Irbesartan Impurity 16 (CAS CATO-C4X-166616)
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