Tuesday, 18 February 2014

WHO update endotoxin guidance


The World health Organization has updated its guidance document on the Bacterial Endotoxin Test. the document is available as a draft for public comment. The document is titled:

“IMPLEMENTATION OF THE 1 REVISED GENERAL MONOGRAPH ON PARENTERAL PREPARATIONS IN THE INTERNATIONAL PHARMACOPOEIA: LIMITS FOR THE TEST FOR BACTERIAL ENDOTOXINS (3.4)”.

With the document, individual monographs on injectable dosage forms in the
International Pharmacopoeia (Ph.Int.) were investigated with a view to add a limit for bacterial endotoxins to each monograph that currently does not include such a requirement. The result of the review is that a number of endotoxin limits have been proposed.

Furthermore, in the new general monograph on Parenteral preparations the following statement is made:

“For powders and concentrates for injections and intravenous infusions, the amount of the preparation to be tested and the nature and volume of the liquid in which it is to be dissolved, suspended or diluted is specified in the individual monograph.”

The new guidance proposes to delete this sentence since the preparation of the sample solution is described in Chapter 3.4 Test for bacterial endotoxins. The text requires that samples should be dissolved or diluted in aqueous solutions so that the final solutions do not exceed the maximum valid dilution (MVD).

The aim is for the document to be implemented in October 2014. The draft can be viewed via the WHO website.

Posted by Tim Sandle