Irbesartan impurities include process-related compounds, degradation products, and structurally related analogs that may arise during synthesis, formulation, or storage. As an angiotensin II receptor antagonist used in the treatment of hypertension and diabetic nephropathy, impurity profiling is essential to ensure product safety, therapeutic efficacy, and regulatory compliance. All impurity compounds are structurally characterized and qualified under ICH guidelines for toxicological evaluation and analytical validation.
We offer pharmacopeial and non-pharmacopeial Irbesartan impurity compounds that conform to European Pharmacopoeia (EP) specifications. These standards support method development, impurity profiling, and stability studies. EP traceable compounds are available upon request and are supplied with validated analytical data including HPLC purity, NMR, and MS characterization.
Our catalog includes structurally related compounds and synthetic intermediates associated with Irbesartan. These compounds are used in forced degradation studies, impurity identification, and toxicological qualification. All entries are supported by comprehensive analytical documentation and meet international regulatory expectations.
Irbesartan impurity reference standards are supplied with validated analytical data including NMR, MS, and HPLC purity. These compounds are used in pharmaceutical R&D, method validation, and GMP-compliant quality control. EP/USP traceable entries are available upon request. All products are re-tested at regular intervals to ensure consistency and reliability.
![4′-(azidomethyl)-[1,1′-biphenyl]-2-carbonitrile | 133690-91-2 | Irbesartan](https://synthinkchemicals.com/wp-content/uploads/2025/04/SA23318.png)
![N-[(2’-Cyano[1,1’-biphenyl]-4-yl)methyl]-1-[(1-oxopentyl)amino]cyclopentanecarboxamide | 141745-71-3 | Irbesartan](https://synthinkchemicals.com/wp-content/uploads/2025/04/SA23317.png)
![2-Butyl-4,4-dimethyl-1-[[2’-(1H-tetrazol-5-yl)[1,1’-biphenyl]-4-yl]methyl]-4,5-dihydroimidazol-5-one | 141745-36-0 | Irbesartan](https://synthinkchemicals.com/wp-content/uploads/2025/04/SA23315.png)
![5-[1,1’-Biphenyl]-2-yl-2H-tetrazole | 147330-32-3 | Irbesartan](https://synthinkchemicals.com/wp-content/uploads/2025/04/SA23314.png)
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