COMPARISON OF SENSITIVITY AND SPECIFICITY OF LAL/TOC ANIMAL PYROGEN (RABBIT) TEST WITH DIFFERENT DILUTIONS OF E.COLI FOR THE ASSESSMENT OF QUALITY OF WFI IN PHARMACEUTICS

Today, parenteral products occupy a particular place in the treatment of diseases
and human health. Consequently, the presence of any microbial contamination in the water used in the
drug production process may have adverse effects on the health of individuals and society. Since
parenteral sera are in direct contact with the human body and blood, they must be free from pyrogens.
The purpose of this study was to evaluate WFI water quality in the pharmaceuticals industry by LAL
test methods and TOC test and rabbit pyrogen test with different dilutions of E. coli.
Materials & Methods: In the present study, the sensitivity and specificity of LOL, TOC, and rabbit
pyrogen tests with different dilutions of E. coli were evaluated to assess the water quality of WFI in the
pharmaceuticals industry. LAL kits, EMB, TOC set, Spectrometer, Colony counter and Rabbits and…
wad used in this study
Results: None of the diluted solutions of E. coli were appropriate for medicinal water. The LAL test
also gave more accurate results than the rabbit test, although it still appears that the LAL test is not
entirely accurate.
Conclusion: The results showed that all methods have advantages and disadvantages compared to one
another, but the use of the TOC device in the thinnest samples demonstrates more acceptable results