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Determination of Bacterial Endotoxin in Glutamic Acid by Kinetic Chromogenic Assay
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Chong WANG, Juntian XU, Zuxuan WANG, Juan HOU, Xiaodong HUA*
Chinese Pharmaceutical Journal | 2025, 60(3) : 302 - 307
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Chinese Pharmaceutical Journal | 2025, 60(3): 302-307
Determination of Bacterial Endotoxin in Glutamic Acid by Kinetic Chromogenic Assay
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Chong WANG, Juntian XU, Zuxuan WANG, Juan HOU, Xiaodong HUA*
Affiliations
  • Tianjin Institute for Drug Control, Tianjin 300070, China
Published: 2025-02-08 doi: 10.11669/cpj.2025.03.013
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OBJECTIVE To establish a method for the quantitative detection of bacterial endotoxin in glutamic acid and verify its feasibility. METHODS Verification test of the reliability of bacterial endotoxin standard curve, interference test of calcium ion buffer and sodium ammonium hydrogen phosphate used in pre-treatment, and interference test of test product and additional endotoxin recovery test were carried out in sequence by using limulus reagents from two manufacturers according to the standard of kinetic chromogenic assay in bacterial endotoxin inspection method (General Chapter 1143 in Chinese Pharmacopoeia2020 Edition). A method for the detection of bacterial endotoxin in glutamic acid was successfully established, and three batches of samples were quantitatively detected by this method. RESULTS Glutamic acid was dissolved with sodium ammonium hydrogen phosphate together to the concentration of 20 mg·mL-1, then diluted by calcium ion buffer to the concentration of 5 mg·mL-1, which had no interference effects on bacterial endotoxin test. The contents of endotoxin in three batches of samples were all lower than the limit of 12 EU·g-1, the RSD values were all lower than 10%, and the endotoxin recovery rates were in the range of 50% to 200%, which met the requirements. CONCLUSION The bacterial endotoxin test method established in this study can be used to detect the bacterial endotoxin in glutamic acid and control its quality.

glutamic acid  /  active pharmaceutical ingredients (API)  /  bacterial endotoxin  /  kinetic chromogenic assay  /  quantitative determination
Chong WANG, Juntian XU, Zuxuan WANG, Juan HOU, Xiaodong HUA. Determination of Bacterial Endotoxin in Glutamic Acid by Kinetic Chromogenic Assay[J]. Chinese Pharmaceutical Journal, 2025 , 60 (3) : 302 -307 . DOI: 10.11669/cpj.2025.03.013
Year 2025 volume 60 Issue 3
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doi: 10.11669/cpj.2025.03.013
  • Receive Date:2024-07-30
  • Online Date:2025-10-29
  • Published:2025-02-08
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  • Received:2024-07-30
Affiliations
    Tianjin Institute for Drug Control, Tianjin 300070, China
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表12种不同金属材料的力学参数

Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)

Genus
种数
Number of
species
占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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