Irbesartan Impurities
General Information
Irbesartan Impurities and Irbesartan
Daicel Pharma offers superior-quality Irbesartan impurities, such as Irbesartan Oxime impurity. Irbesartan impurities are vital for evaluating the quality, stability, and biological safety. In addition, Daicel Pharma specializes in the custom synthesis of Irbesartan impurities and ensures their worldwide delivery.
Irbesartan [CAS: 138402-11-6] is a biphenyl tetrazole compound. It inhibits angiotensin II type 1 receptors. It blocks the vasoconstriction caused by angiotensin II and lowers blood pressure. In addition, it inhibits the renin-angiotensin system and slows nephropathy in patients with type 2 diabetes.
Irbesartan: Use and Commercial Availability
Irbesartan treats hypertension and diabetic nephropathy. It decreases blood pressure and increases blood supply to the heart. Further, it helps prevent strokes, heart attacks, and kidney problems. It combines with other medicines like diuretics for treating patients with hypertension. Irbesartan is available as an oral formulation under the brands Avapro and Karvea.
Irbesartan Structure and Mechanism of Action
The chemical name of Irbesartan is 2-Butyl-3-[[2′-(2H-tetrazol-5-yl)[1,1′-biphenyl]-4-yl]methyl]-1,3-diazaspiro[4.4]non-1-en-4-one. The chemical formula for Irbesartan is C25H28N6O, and its molecular weight is approximately 428.53 g/mol.
Irbesartan stops angiotensin II binding to the (AT1 subtype) receptor in tissues. Hence, it relaxes vascular smooth muscles and decreases aldosterone secretion.
Irbesartan Impurities and Synthesis
When synthesizing Irbesartan 1, the formation of impurities may affect drug safety and efficacy. They develop during the manufacturing process, storage, or purification of Irbesartan. Irbesartan impurities need control and monitoring to improve the drug safety, efficacy, and storage.
Daicel Pharma offers a comprehensive Certificate of Analysis (CoA) for Irbesartan impurities, which includes Irbesartan Oxime impurity. We provide the CoA from a cGMP-compliant analytical facility. The CoA has the complete characterization data such as 1H NMR, 13C NMR, IR, MASS, and HPLC purity2. We give additional spectral data on request. Daicel Pharma can prepare any unidentified Irbesartan impurity or degradation product. In addition, Daicel Pharma offers a highly purified, stable isotope-labeled standard of Irbesartan. Daicel Pharma provides a complete characterization report accompanying the delivery.
References
FAQ's
References
- Bernhart, Claude; Breliere, Jean Claude; Clement, Jacques; Nisato, Dino; Perreaut, Pierre, N-substituted heterocycle derivatives, their preparation, compositions containing them, EP454511B1, Jun 17, 1998, Sanofi SA, France (https://www.lens.org/lens/search/patent/list?q=EP0454511B1)
- Chang, Shu-Ying; Whigan, Daisy B.; Vachharajani, Nimish N.; Patel, Rajesh, High-performance liquid chromatographic assay for the quantitation of irbesartan (SR 47436/BMS-186295) in human plasma and urine, Journal of Chromatography B: Biomedical Sciences and Applications, Volume: 702, Issue: 1 + 2, Pages: 149-155, 1997 DOI: (10.1016/s0378-4347(97)00387-3)
Frequently Asked Questions
2.Which analytical method identifies the principal impurities of Irbesartan that form in the drug?
Proton and carbon NMR spectroscopy identifies the principal impurities of Irbesartan.
3.What are the process-related impurities of Irbesartan?
Irbesartan's process related impurities are Pentanoic acid (2'-cyano-biphenyl-4-ylmethyl)-amide, N-(2'-cyano-biphenyl-4-yl-methyl-2,2,2-trifluoro-acetamide, pentanoic acid (2'-1H-tetrazol-5-yl)-biphenyl-4- ylmethyl)-amide, 3-[2'-1H-tetrazol-5-yl)-biphenyl-4-ylmethyl]-l, 3-diaza-spiro [4,4] non-1-en-4-one, and 2,2,2-trifluoro-N-[2'- (1H-tetrazol-5-yl)-biphenyl-4-ylmethyl]-acetamide.
4.Why is it necessary to remove Irbesartan impurities from the drug?
Irbesartan impurities removal is necessary for large-scale API production and commercialization of the drug.
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