Bacterial Endotoxins Test

The FDA has published Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions Annex 14 Bacterial Endotoxins Test General Chapter This annex is one in a series of guidance documents that describe the evaluations and recommendations by the Q4B Expert Working Group (EWG) of selected pharmacopoeial texts to facilitate their recognition by regulatory authorities for use as interchangeable in the ICH regions. Implementation of the Q4B annexes is intended to avoid redundant testing by industry.

The analytical procedures described in the official pharmacopoeial texts, European Pharmacopoeia (Ph. Eur.): 2.6.14. Bacterial Endotoxins, Japanese Pharmacopoeia (JP): 4.01 Bacterial Endotoxins Test, and United States Pharmacopeia (USP) General Chapter <85> Bacterial Endotoxins Test, can be used as interchangeable in the ICH regions subject to the following conditions:

Any of the three techniques can be used for the test. In the event of doubt or dispute, the gel-clot limit test should be used to make the final decision on compliance for the product being tested.

The USP, JP, and Ph. Eur. reference standards are considered interchangeable because they have been suitably calibrated against the WHO (World Health Organization) International Standard for Endotoxin.

In the section Photometric quantitative techniques, Preparatory testing, Test for interfering factors, the user should perform the test on solutions A, B, C, and D on at least two replicates using the optimal conditions as recommended by the lysate manufacturer.

For further details, see BET.

Posted by Tim Sandle