SHEN Juan, LU Jiayue, LUO Xiaoru, WANG Xiwen. Validation of endotoxin test for high concentration vitamin B6 injection[J]. Journal of Pharmaceutical Practice and Service, 2020, 38(1): 67-70. doi: 10.3969/j.issn.1006-0111.201909108
| Citation:
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SHEN Juan, LU Jiayue, LUO Xiaoru, WANG Xiwen. Validation of endotoxin test for high concentration vitamin B6 injection[J]. Journal of Pharmaceutical Practice and Service, 2020, 38(1): 67-70. doi: 10.3969/j.issn.1006-0111.201909108
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Validation of endotoxin test for high concentration vitamin B6 injection
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General Station for Drug&Instrument Supervision and Control, Joint Logistics Support Force, PLA, Beijing 100071, China
- Received Date: 2019-09-25
- Rev Recd Date:
2019-11-08
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Abstract
Objective To establish a bacterial endotoxin test method for high concentration vitamin B6 injection. Method The test was taken according to the bacterial endotoxin test in Chinese pharmacopoeia 2015 edition. Result By diluting the sample concentration to 1.04 mg/ml with the buffer of pH6.5-7.5, and using λ=0.06 EU/ml of TAL reagent, the interference could be effectively avoided. Conclusion The method was useful, which could be used to test the bacterial endotoxin in high concentration vitamin B6 injection. The bacterial endotoxin limit was defined as 0.06 EU/mg.
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