General Information

Elobixibat Impurities and Elobixibat

Daicel Pharma offers high-quality impurities for Elobixibat, an active pharmaceutical ingredient. These impurities, including Elobixibat acid Impurity, Elobixibat Acid Methyl Ester Impurity, Elobixibat Methyl Ester Impurity, and Elobixibat Phenol Impurity, play a vital role in assessing the purity, reliability, and safety of Elobixibat. Daicel Pharma also offers a customized synthesis of Elobixibat impurities to cater to client requirements, with worldwide delivery options available.

Elobixibat [CAS: 439087-18-0] treats Dyslipidemia, Constipation, Chronic Constipation, Functional Constipation, and Chronic Idiopathic Constipation. Elobixibat modulates the circulation of bile acids (BAs) within the enterohepatic system. It enhances the transportation of BAs to the colon, where they induce secretory and motor effects.

Elobixibat: Use and Commercial Availability  

Elobixibat, available under Goofice, is a first-in-class drug for treating chronic constipation and constipation-predominant irritable bowel syndrome (IBS-C). It acts by inhibiting the ileal bile acid transporter, reducing the absorption of bile acids in the ileum. It allows bile to stimulate colonic secretion and contractions, thereby accelerating the movement of the colon. Elobixibat is minimally absorbed into the bloodstream when taken orally.

Elobixibat Structure and Mechanism of Action

The chemical name of Elobixibat is (2R)-N-[2-[[3,3-Dibutyl-2,3,4,5-tetrahydro-7-(methylthio)-1,1-dioxido-5-phenyl-1,5-benzothiazepin-8-yl]oxy]acetyl]-2-phenylglycylglycine. Its chemical formula is C₃₆H₄₅N₃O₇S_2, and its molecular weight is approximately 695.9 g/mol.

Elobixibat inhibits the ileal bile acid transporter and accelerates colonic transit.

Elobixibat Impurities and Synthesis

The analysis and control of impurities in Elobixibat, a medication used for chronic constipation, is vital to ensure its safety and efficacy. Analytical techniques such as chromatography, spectroscopy, and mass spectrometry help identify and quantify impurities in Elobixibat. Impurity profiling aids in understanding the chemical composition, structure, and potential hazards associated with drug impurities. Stringent control measures during the manufacturing process¹ help minimize impurity formation. Regulatory guidelines establish acceptable limits for Elobixibat impurities in pharmaceutical products, and thorough analysis and control are crucial for maintaining their quality and therapeutic effectiveness of patients.

Daicel Pharma offers a comprehensive Certificate of Analysis (CoA) for Elobixibat impurity standards, including Elobixibat acid Impurity, Elobixibat Acid Methyl Ester Impurity, Elobixibat Methyl Ester Impurity, and Elobixibat Phenol Impurity. They generate from an analytical facility that complies with cGMP standards. The CoA provides a detailed characterization report with data obtained through techniques such as 1H NMR, 13C NMR, IR, MASS, and HPLC purity analysis². We provide additional data like 13C-DEPT upon request. Daicel Pharma synthesizes unknown Elobixibat impurities or degradation products. Every delivery has a complete characterization report.