USP <85>Bacterial Endotoxin Test - proposed interim Revision Announcement

In the pharmacopeial Forum Volume 36, No. 6, the USP published a proposed interim revision announcement of  chapter <85> "Bacterial Endotoxin Test". This chapter includes information about the three techniques for the Bacterial Endotoxin Test (BET), the gel-chlot technique, the chromogenic technique and the turbidimetric technique to detect or quantify endotoxins from gram-negative bacteria using amoebocyte lysate of the horseshoe crab. Some parts of this chapter have been harmonised with the European Pharmacopoeia and the Japanese Pharmacopoeia.  

The follwing revisions are proposed:

  • (1) on the basis of an FDA recommendation, change the calculation of the limit for endotoxins in products dosed by body surface area, appearing in non harmonised footnote 2
  • (2) add a previously deleted sentence to the harmonised text in Gel Clot Technique, Test for Interfering Factors.

The USP intends to implement this revision through an Interim Revision Announcement with an official date of April 1, 2011.

Please be aware of the ECA education course "Endotoxin and Pyrogen Testing" in Heidelberg, Germay, from 28-29 June 2011. This course will inform you about current developments in Endotoxin and Pyrogen testing as well as the practical use of established test system like LAL for Endotoxin testing. Speakers from authority and industry will share their experience with you.

Author:
Axel Schroeder
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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