Journal of Pharmaceutical Practice and Service 2025;43(12):607-609

doi:10.12206/j.issn.2097-2024.202508061

Study on bacterial endotoxin limit value and the detection methodological investigation for the active pharmaceutical ingredient of pentetic acid

Juan SHEN 1 ; Ying TIAN 2 ; Ming NI 1 ; Ju LIU 1 ; Mengmeng YU 1

Affiliations

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Keywords

pentetic acid; endotoxin limit; methodological investigation

Country

China

Language

Chinese

Abstract

Objective To explore and establish the bacterial endotoxin limit value and testing method of the active pharmaceutical ingredient （API） of pentetic acid, and conduct methodological investigation. Methods Three batches of pentetic acid were used to establish the method for the determination of bacterial endotoxin, and interference test was conducted simultaneously. The sample was dissolved with commercially available alkaline regulator to a concentration of 4 mg/ml or lower, and then diluted with water for bacterial endotoxin test. Limulus reagent with sensitivity of 0.125 EU/ml or higher was selected and redissolved with commercially available magnesium ion buffer solution. And the endotoxin test was performed by gel method. Results The endotoxin limit of API of pentetic acid was determined as: less than 0.125 EU/mg. Conclusion The method established could be used for the control of bacterial endotoxin in API of pentetic acid.