Abstract: Lobaplatin and lobaplatin for injection have been included in the Chinese Pharmacopoeia 2025 Edition(VolumeⅡ). The establishment of pharmacopoeia standards is of significant importance for ensuring drug quality and clinical medication safety. This article focused on a detailed analysis of the drafting process of the related substances item for lobaplatin, and systematically expounded the ideas and establishment process of pharmacopoeia standards for lobaplatin active pharmaceutical ingredient(API) and its injection formulation, and also provided a reference for improvement of national drug standards and establishment of the pharmacopoeia standards.