Study on bacterial endotoxin limit value and the detection methodological investigation for the active pharmaceutical ingredient of pentetic acid
10.12206/j.issn.2097-2024.202508061
- VernacularTitle:喷替酸原料药细菌内毒素限值确定及检查方法学研究
- Author:
Juan SHEN
1
;
Ying TIAN
2
;
Ming NI
1
;
Ju LIU
1
;
Mengmeng YU
1
Author Information
1. General Station for Drug & Instrument Supervision and Control, Joint Logistics Support Force, PLA, Beijing 100166, China.
2. Beijing Institute of Radiation Medicine, Beijing 100850, China.
- Publication Type:Researchreports
- Keywords:
pentetic acid;
endotoxin limit;
methodological investigation
- From:
Journal of Pharmaceutical Practice and Service
2025;43(12):607-609
- CountryChina
- 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.
