Quality assessment of cholic acid as an active pharmaceutical ingredient: Analytical method and results

Commercial cholic acid (CA) treatment is currently unavailable to Dutch patients with a bile acid synthesis defect. CA treatment has been hypothesized to correct the biochemical abnormalities associated with these disorders and potentially slowing down disease progression. To address this need, the hospital pharmacy of Amsterdam University Medical Center developed CA capsules for use in a clinical trial in The Netherlands. Challenges arose during the quality control of CA active pharmaceutical ingredient (API) as no specific substance monograph is available in the European Pharmacopoeia or other effective pharmacopoeias. In this article, we share an analytical method validated for testing the purity of CA and present the results of its quality control, offering practical guidance for ensuring adequate quality control of CA. Pharmaceutical quality tests were performed on four batches of CA following the guidance given in the European Pharmacopoeia general monograph on substances for pharmaceutical use. The results confirm the suitability of our analytical method for CA quality control and demonstrate that the CA meets the high-quality standards required for pharmaceutical use.