Obeticholic acid (OCA) is a semisynthetic bile acid derivative, whose structure consists of a β-steroid nucleus and four substituents.
It is a first-line farnesyl ester X receptor (FXR) agonist. Its ability to activate FXR is 100 times stronger than that of another commonly used drug, UDCA.
The drug was approved for marketing by the FDA and the European Union in 2016, and is the first drug approved for the treatment of PBC in nearly 20 years.
| Test Item | Specification | Results |
| Assay | 98.0% ~ 102.0% (Calculated on the anhydrous basis) | 98.6% |
| Appearance | White to almost white solid | White solid |
| Identification | The retention time of the major peak of the Sample solution corresponds to that of the Standard solution,as obtained in the Assay. | Conforms |
| Water | ≤ 2.0% | 1.4% |
| Heavy metal | ≤ 20 ppm | Conforms |
| Related substances | ACS9037-1 ≤ 0.15% | 0.04% |
| ACS9037-9 ≤ 0.15% | Negative | |
| Other single impurity ≤ 0.15% | 0.08% | |
| Total impurities ≤ 1 % | 0.18% | |
| Residual solvent | Heptane ≤ 0.5% | Negative |
| Methylene chloride ≤ 0.06% | Negative | |
| Ethyl acetate ≤ 0.5% | Negative | |
| Acetonitrile ≤ 0.041% | 0.0045% | |
| Toluene ≤ 0.089% | Negative | |
| Conclusion: | Meet the standard | |
Obeticholic acid is a globally marketed drug used to treat:
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