| CAS No. | 1821386-21-3 |
| Molecular Formula | C22H18N4O4 |
| Molecular Weight | 402.40 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
The occurrence of Azilsartan Impurity 8 is closely related to a flavonoid core, an amide group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.
CATO supplies Azilsartan Impurity 8 (CAS 1821386-21-3), a pharmacopoeial impurity reference standard (molecular formula C22H18N4O4, MW 402.40 g/mol) used for the identification and quantification of trace impurities in APIs.
Structurally, Azilsartan Impurity 8 (C22H18N4O4) contains a flavonoid core, an amide group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 16.0, corresponding to approximately 16 ring(s) or double-bond equivalent(s). With a molecular weight of 402.40 g/mol, it falls into the moderately-high-molecular-weight range. 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.
| Molecular Formula | C22H18N4O4 |
| Molecular Weight | 402.40 g/mol |
| Appearance | Pale yellow to yellow crystalline powder |
| 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 |
| Degree of Unsaturation (DBE) | 16.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1995 |
| Nitrogen Atoms | 4 |