Aspartic acid, as an amino acid active pharmaceutical ingredient (API), has been widely used in various pharmaceutical preparations, especially in amino acid injection. Therefore, quality control of aspartic acid should be strengthened. Currently, both domestic and foreign pharmacopoeias have records of aspartic acid content and related substance detection methods. In recent years, with the advancement of consistency evaluation of formulated drugs, the control of relevant substances in pharmaceutical preparations has become one of the important evaluation indicators. The use of aspartic acid API and their derivative in pharmaceutical preparations, especially in injections, has attracted more attention for its related substances. This article reviews the relevant substances of aspartic acid API based on pharmacopoeia, literature, and enterprise research, in order to provide a basis for comprehensive quality control of aspartic acid API.
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