Background

Endotoxin, present in the outer membrane of all Gram-negative bacteria, such as E. coli, Salmonella, Pseudomonas, Haemophilus, and other pathogens, causes fever, pain, irreversible shock, and even death. The Limulus amebocyte lysate (LAL) test is an alternative method to the rabbit pyrogen test focused on the detection of pyrogenic substances in sterile parenteral drugs.

Purpose of the study

The study aimed to detect the bacterial endotoxin using LAL tests in ceftriaxone and water for injection in an industrial setup.

Methodology

This is a cross-sectional study carried out at Saydon Pharmaceutical, an industrial area Peshawar from March to July 2023. Limulus Amoebocyte Lysate (gel clot method) test was performed to detect bacterial endotoxin in a total of 60 samples of water ampoules and ceftriaxone sodium in the pharmaceutical industry.

Results

The 60 samples of water ampoules and ceftriaxone sodium from various pharmaceuticals were analyzed to check for bacterial endotoxins. All the samples of water ampoules and ceftriaxone sodium were found to be negative for endotoxin.

Conclusion

In the present study, we conclude that there are no endotoxins present in the study samples, and we recommend that these injections and the water for injections are safe for human health.

Keywords: Endotoxin, Pyrogen, LAL, Rabbit pyrogen test