Clinical Microbiology: Open Access

A rapid and reliable monitoring of endotoxin from pharmaceutical products

8^th CLINICAL MICROBIOLOGY CONFERENCE

October 26-28, 2017 | Paris, France

Moatter Jan, Shaziat Hakim and Sayyada G Nadeem

Jinnah University for Women, Pakistan

Posters & Accepted Abstracts: Clin Microbiol

Abstract:

Statement of the Problem: Toxins of the micro-organism are considered a real threat, especially endotoxins; Lipopolysaccharides that are particularly secreted after the death and cell lysis of gram-negative bacteria. Endotoxin could be defined as �??Toxin which is released by microbes after their death by the administration of parental antibiotics�??. Methodology: In the light of these hypotheses, a study was conducted for rapid detection and quantification of endotoxin in injectable drugs. A total of 100 pharmaceutical drugs was provided for the present study in injectable form. They were manufactured by different pharmaceutical companies and were also obtained from different localities (20 drugs/area). Limulus Amoebocyte Lysate (LAL) endpoint chromogenic method was used for the measurement of endotoxin levels. Results: A total of 48% parenteral drugs was found endotoxin positive with levels above the permissible limits; while 52% were found negative (below the permissible limits). The sensitivity and specificity varied from 98.6% to 96.6%. Based on statistical analysis, this study showed that there was a trend of positive linear correlation between absorbance and concentration of endotoxin found in drug samples, since the calculated Pearson coefficient correlation value was 0.998 and found significant at P < 0.100. Conclusion: By testing several drug samples available in the local markets of a metropolis, it is suggested that these products should be manufactured by following the appropriate current Good Manufacturing Practice (cGMP) and the establishment of reporting systems and quality-control testing with the intention to improve drug quality. Large-scale studies are further recommended for further understanding the magnitude of this important problem and finding its solution.