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Evaluation of bacterial endotoxin contamination in parenteral injections under the Drug Quality Assurance Program
  • 4.12.2017
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Evaluation of bacterial endotoxin contamination in parenteral injections under the Drug Quality Assurance Program
Owner / Producer Owner / Producer
Paveena Charoensit, Dawsupya Chaisomboonpan, Rassadaphorn Kongmoung
Year Year
2016
Pages Pages
8
Details

The bacterial endotoxins test was used to measure the levels of bacterial endotoxin contamination in 248 samples from 16 parenteral injections under the Drug Quality Assurance Program. The interference test and kinetic turbidimetric method for the determination of endotoxin in each sample were performed simultaneously. The concentration used in this study did not inhibit or enhance with the detection of endotoxin with Limulus test. The resulting data is a useful information for manufacturers in setting up a suitable concentration for bacterial endotoxins testing. Furthermore, the results showed that all samples contained endotoxin level less than endotoxin limit. The quality and safety of parenteral drugs used in public hospitals all over the country met the requirement of bacterial endotoxin test.