Irbesartan Impurity 48 CAS 253269-07-7
| CAS No. | 253269-07-7 |
| Molecular Formula | C11H20N2O2 |
| Molecular Weight | 212.29 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
The occurrence of Irbesartan Impurity 48 is closely related to an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.
Irbesartan Impurity 48 (CAS 253269-07-7) is a certified pharmaceutical impurity reference standard with the molecular formula C11H20N2O2 and a molecular weight of 212.29 g/mol.
Structurally, Irbesartan Impurity 48 (C11H20N2O2) contains an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 3.0, corresponding to approximately 3 ring(s) or double-bond equivalent(s). With a molecular weight of 212.29 g/mol, it falls into the medium-molecular-weight range. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.
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 | C11H20N2O2 |
| Molecular Weight | 212.29 g/mol |
| Appearance | White to pale yellow crystalline powder |
| Purity | ≥95% |
| Storage | Store at 2-8°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) | 3.0 |
| UV Absorption | UV-absorbing |
| CAS Registry Year (est.) | 2025 |
| Nitrogen Atoms | 2 |
Related Irbesartan Standards
- Irbesartan Impurity 2 (CAS 177219-40-8)
- Irbesartan Impurity 42 (CAS CATO-C4X-166642)
- Irbesartan Impurity 44 (CAS CATO-C4X-166644)
- Irbesartan Impurity 46 (CAS CATO-C4X-166646)
- Irbesartan Impurity 23 (CAS CATO-C4X-166623)
- Irbesartan Impurity 3 (CAS 15026-80-9)
- Irbesartan impurity 37 (CAS 1415462-83-7)
- Irbesartan Impurity 17 (CAS CATO-C4X-166617)
Recommended Standards
- Brivaracetam (CAS 357336-20-0)
- Brivaracetam impurity 104 (CAS 357334-83-9)
- Brivaracetam Impurity 131 (CAS CATO-C4X-2007131)
- Brivaracetam Impurity 144 (CAS CATO-C4X-2007144)
- Edoxaban Impurity 75 (CAS 1255529-31-7)
- Trandolapril Impurity 7 (CAS CATO-C4X-17707)
- Carbazochrome Impurity 7 (CAS CATO-C4X-22917)
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- 1-(1-(Difluoromethyl)-1H-pyrazol-5-yl)-N-((1-propyl-1H-pyrazol-3-yl)methyl)methanamine hydrochloride (CAS 1856081-78-1)
- N-(1-((3-(trifluoromethyl)phenyl)sulfonyl)piperidin-4-yl)benzamide (CAS 860788-10-9)
- Pyridoxine Impurity 50 HCl (CAS CATO-C4X-187750)
- (2R,4R)-4-fluoropyrrolidine-2-carbonitrile (CAS 1637365-35-5)
- D-NMAPPD (CAS 35922-06-6)
- Hexapeptide-11 (CAS 161258-30-6)
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