By comparing the quality standards of histidine hydrochloride in pharmacopoeias of various countries,the optimization and improvement projects for the quality standards of histidine hydrochloride for pharmaceutical ex-cipients in the 2025 edition of the Chinese Pharmacopoeia are clarified,and the description of this standard is standardized according to the requirements of the"Detailed Rules for the Compilation of National Pharmaceutical excipient Standards".This article aims to clarify the key research content of the quality standard formulation process for medicinal excipient histidine hydrochloride,to provide a deeper understanding of this standard for drug regulatory agencies,production enterprises,and other practitioners.

By comparing the quality standards of histidine hydrochloride in pharmacopoeias of various countries,the optimization and improvement projects for the quality standards of histidine hydrochloride for pharmaceutical ex-cipients in the 2025 edition of the Chinese Pharmacopoeia are clarified,and the description of this standard is standardized according to the requirements of the"Detailed Rules for the Compilation of National Pharmaceutical excipient Standards".This article aims to clarify the key research content of the quality standard formulation process for medicinal excipient histidine hydrochloride,to provide a deeper understanding of this standard for drug regulatory agencies,production enterprises,and other practitioners.