ScholarLens Back to search
2011•Zhongguo yaofangRequires access

Establishment of Bacterial Endotoxins Test for Multi-trace Elements Injection(II)

Meng De-sheng

Open publisher page 0 citations

Abstract

OBJECTIVE: To establish bacterial endotoxin test for Multi-trace elements injection(Ⅱ). METHODS: Based on bacterial endotoxin test stated in the second part of Chinese Pharmacopeia (2010 edition), the limit value of the bacterial endotoxin was defined firstly. Interference pre-test and interference test were conduced on 3 batches of samples from 2 manufacturers to confirm non-interfering concentration. The bacterial endotoxin test of samples was carried out. RESULTS: The limit value of the bacterial endotoxin was 20 EU·mL-1. 160 times diluted samples didn’t intervene in bacterial endotoxin test. The bacterial endotoxin test of 3 bathes of samples was in line with the demand. CONCLUSION: The established method is applicable for bacterial endotoxin test of Multi-trace elements injection(Ⅱ).

About this research paper

What this paper is about

OBJECTIVE: To establish bacterial endotoxin test for Multi-trace elements injection(Ⅱ). METHODS: Based on bacterial endotoxin test stated in the second part of Chinese Pharmacopeia (2010 edition), the limit value of the bacterial endotoxin was defined firstly. Interference pre-test and interference test were conduced on 3 batches of samples from 2 manufacturers to confirm non-interfering concentration. The bacterial endotoxin test of samples was carried out. RESULTS: The limit value of the bacterial endotoxin was 20 EU·mL-1. 160 times diluted samples didn’t intervene in bacterial endotoxin test. The bacterial endotoxin test of 3 bathes of samples was in line with the demand. CONCLUSION: The established method is applicable for bacterial endotoxin test of Multi-trace elements injection(Ⅱ).

Why it matters

A significance statement is not available in the OpenAlex record.

Key contribution

A contribution statement is not available in the OpenAlex record.

Method / approach

Method details are not available in the OpenAlex metadata.

Main findings

Findings are not separately available in the OpenAlex metadata.

Limitations

Limitations are not available in the OpenAlex metadata.

Applications

Application details are not available in the OpenAlex metadata.

Available abstract

OBJECTIVE: To establish bacterial endotoxin test for Multi-trace elements injection(Ⅱ). METHODS: Based on bacterial endotoxin test stated in the second part of Chinese Pharmacopeia (2010 edition), the limit value of the bacterial endotoxin was defined firstly. Interference pre-test and interference test were conduced on 3 batches of samples from 2 manufacturers to confirm non-interfering concentration. The bacterial endotoxin test of samples was carried out. RESULTS: The limit value of the bacterial endotoxin was 20 EU·mL-1. 160 times diluted samples didn’t intervene in bacterial endotoxin test. The bacterial endotoxin test of 3 bathes of samples was in line with the demand. CONCLUSION: The established method is applicable for bacterial endotoxin test of Multi-trace elements injection(Ⅱ).

Key concepts: Detection limit, Microbiological culture, Test (biology), Microbiology, Chemistry, Chromatography, Biology, Bacteria

Related papers

Related paper 1Related paper 2Related paper 3
Back to paper searchBrowse research topicsOriginal source
Establishment of Bacterial Endotoxins Test for Multi-trace Elements Injection(II) — Research Paper | ScholarLens