General Information

Obeticholic Acid Impurities and Obeticholic Acid

Daicel Pharma offers Obeticholic Acid impurities such as Obeticholic acid Methyl Ester, Obeticholic Acid, OCA 3 Glucuronide, Stage-III Obeticholic acid, etc. These impurities are essential for evaluating the quality, stability, and safety of Obeticholic Acid, an active pharmaceutical ingredient. Moreover, Daicel Pharma provides custom synthesis of Obeticholic Acid impurities and distributes them internationally to fulfill the client’s needs.

Obeticholic Acid [CAS: 459789-99-2] is a semisynthetic bile acid that treats primary biliary cholangitis. It is a farnesoid X receptor agonist and a hepatoprotective drug. It is structurally similar to chenodeoxycholic acid.

Obeticholic Acid: Use and Commercial Availability 

Obeticholic acid treats primary biliary cholangitis (PBC) with ursodeoxycholic acid (UDCA) for adults who have not responded adequately to UDCA alone. It is used for adults with PBC unable to tolerate UDCA. Obeticholic acid is available as Ocaliva.

Obeticholic Acid Structure and Mechanism of Action

The chemical name of Obeticholic acid is (3α,5β,6α,7α)-6-Ethyl-3,7-dihydroxycholan-24-oic acid. Its chemical formula is C₂₆H₄₄O4, and its molecular weight is approximately 420.6 g/mol.

Obeticholic acid binds to the farnesoid X receptor (FXR), which regulates bile acid. It decreases hepatic exposure to bile acids.

Obeticholic Acid Impurities and Synthesis

Obeticholic Acid (OCA) impurities refer to undesired substances that may be present in the drug formulation of Obeticholic Acid. These impurities can arise during the synthetic process¹ or storage and include related compounds, degradation products, and residual solvents. Controlling and monitoring them is essential to ensure the quality, safety, and efficacy of Obeticholic Acid.

Daicel provides a Certificate of Analysis (CoA) of Obeticholic Acid impurity standards like Obeticholic acid Methyl Ester, Obeticholic Acid, OCA 3 Glucoronide, Stage-III obeticholic acid. Our cGMP-compliant analytical laboratory provides the CoA, which contains extensive characterization data such as 1H NMR, 13C NMR, IR, MASS, and HPLC purity². We give additional characterization data, such as 13C-DEPT, on request. Daicel Pharma has the expertise and capabilities to offer unknown impurities or degradation products of Obeticholic Acid.