Introduction

The normal intravenous human immunoglobulin is a sterile liquid or lyophilized preparation, with immunoglobulins, especially the immunoglobulin G (IgG). The National Institute for Quality Control in Health (NIQCH) performs analysis of biological products before being distributed to the population. The batches are subjected to physicochemical and biosafety assays. The rabbit pyrogen test (RPT) is a biosafety assay performed to check the contamination by agents that cause fever in the patient and, in cases of high concentration, can lead to death.

Aim

To compare the results of RPT and bacterial endotoxins assays of ten samples.

Methods

In RPT, both the product is injected into the rabbit's marginal ear vein and the individual body temperature variations of the animals are evaluated. The bacterial endotoxin assay uses the kinetic chromogenic method, according to the Brazilian Pharmacopoeia and the international compendiums.

Results

The tests of were plotted in a table for comparison. The tests coincided in 9 samples, except for a sample that presented bacterial endotoxin pyrogenicity.

Conclusion

Bacterial endotoxin assay must be considered as an alternative method for animal tests.