<85> Bacterial Endotoxins Test

Type of Posting: 
Notice of Adoption of Harmonized Standard
Official Date: 
Expert Committee: 
General Chapters—Microbiology

A harmonized standard for <85> Bacterial Endotoxins Test has been approved by the Pharmacopeial Discussion Group (PDG) as described in its PDG Sign-Off Cover Page. Having reached Stage 6 of the PDG process, the <85> Bacterial Endotoxins Test General Chapter has been formally approved by the USP General Chapters—Microbiology Expert Committee in accordance with the Rules and Procedures of the 2010–2015 Council of Experts.

Changes from the existing USP–NF General Chapter include:

  • In the Introduction, replacing the term gel clot technique with Gel Clot Limit Test relating to the referee method in the event of a dispute.
  • In the subsection on Sample Solutions, deleted the description pertaining to medical devices from the harmonized text.
  • Deleted the term “regression” from the harmonized text in the section on DETERMINATION OF MAXIMUM VALID DILUTION (MVD).

The <85> Bacterial Endotoxins Test General Chapter will be incorporated into and become official with the Second Supplement to USP 35–NF 30.

Should you have any questions about the <85> Bacterial Endotoxins Test General Chapter, please contact Radhakrishna Tirumalai (301-816-8339 or rst@usp.org). For any questions about the PDG and its processes, please see the Pharmacopeial Harmonization Web page or contact Mario Sindaco (301-816-8246 or mys@usp.org).