Abstract:
The oxidation monitoring of lipid-based pharmaceutical excipients is crucial for ensuring the quality and safety of pharmaceutical products. The oxidation indexes applicable to lipid-based pharmaceutical excipients currently included in the pharmacopoeias of various countries encompass the peroxide value, anisidine value, and total oxidation value. Additionally, indexes such as the conjugated diene value, thiobarbituric acid value, and carbonyl value, which are not officially included in the pharmacopoeia but have been documented in relevant industry standards and literature, are also used to assess the oxidative status of lipid-based pharmaceutical excipients. This review examines the current research on these oxidation indexes for lipid-based pharmaceutical excipients, and analyzes their applicability, limitations, and challenges, aiming to provide some reference for the oxidation monitoring of lipid-based pharmaceutical excipients.