Obeticholic Acid Related Compounds & Impurities

Obeticholic Acid is a farnesoid X receptor (FXR) agonist used for primary biliary cholangitis not adequately responding to ursodeoxycholic acid.

Simson Pharma Limited along with its subsidiary offices Simson Pharma Global Ltd. (UK) and Simson Pharma Global LLC (USA) is a trusted manufacturer and supplier of high-quality pharmaceutical reference standards, offering a comprehensive portfolio of Obeticholic Acid reference standards, pharmacopeial and non-pharmacopeial Obeticholic Acid impurities, related compounds, related substances, metabolites, stable isotope-labelled compounds, deuterium labelled compounds and nitrosamine (N-NO) reference standards.

These materials support pharmaceutical research and development, product development, ANDA and DMF submissions, quality control (QC), analytical method development and validation, stability studies, impurity identification, and genotoxic impurity assessment.

Our Obeticholic Acid-related reference standards are thoroughly characterized using advanced analytical techniques and are supplied with comprehensive Certificates of Analysis (COA) and supporting analytical data from our USFDA certified, ISO 17025 and ISO 17034 accredited Lab, to meet global regulatory expectations. EP and USP traceable reference standards can also be provided upon request, subject to availability. Simson is also a provider of EP and USP traceable standards. To ensure consistent quality and reliability, our reference standards are periodically re-tested according to established quality management procedures.

Pharmaceutical Reference Standards / Impurity Standards

Obeticholic Acid
Obeticholic Acid Impurity 2
Obeticholic Acid Impurity 3
Obeticholic Acid Impurity 1
Obeticholic Acid Impurity 9
3,7-dioxo-5beta-cholanic acid
Obeticholic Acid Impurity 5
Glyco Obeticholic Acid
Tauro Obeticholic Acid
Obeticholic Acid Dimer
3-Oxo-7alpha-hydroxy-5beta-cholanoic Acid
Hyocholic Acid
Nutriacholic Acid Methyl Ester
Obeticholic Acid Triol Impurity
Obeticholic Acid Impurity 6
Obeticholic Acid-[PEG]-n-Ester.
Methyl (3alpla,5beta)-3,7-Bis[(trimethylsilyl)oxy]chol-6-en-24-oate
Methyl 3-alpha-Acetoxy-6-ethyl-7-keto-5-beta-cholanate
(E/Z)-3-alpha-hydroxy-6-ethylidene-7-keto-5-beta-cholan-24-oic acid Methyl ester
(E)-2,3-dihydroxypropyl 3-(4-(hexadecyloxy)phenyl)-2-methylacrylate
Obeticholic Acid Keto Ester Impurity
(3 alpha,5 beta)-3-[(Ethoxycarbonyl)oxy]chol-6-en-24-oic Acid Methyl Ester
Obeticholic Acid Impurity 4
Obeticholic Acid Isomer-2 Impurity
Obeticholic Acid Impurity 7
6beta-Ethyl-7-Keto-Obeticholic Acid
Obetocholic Acid Impurity I
(E)-3alpha-Hydroxy-6-ethylidene-7-keto-5beta-cholan-24-oic Acid
Obeticholic Acid Impurity 13
Obeticholic Acid Dimer Impurity
Obeticholic Acid Impurity 14
Obeticholic Acid Impurity 15
Obeticholic Acid Impurity 8

Metabolites

Obeticholic acid 3-O-beta-D-glucuronide
Obeticholic acid acyl-beta-D-glucuronide
Tauro-6-Ethylchenodeoxycholic Acid Sodium Salt

Isotope Labelled Compounds

Obeticholic Acid-D5 Sodium Salt
Glyco-Obeticholic Acid-D5
Tauro Obeticholic acid D5 Sodium Salt