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Proposed New Chapter <1085> Guidelines on Endotoxins Test

Type of Posting: General Announcement
Posting Date: 26–Jan–2018
Expert Committee: General Chapters—Microbiology
Input Deadline:28–Feb–2018

Suggested audience: Pharmaceutical, Biotech, Medical Device Industries, Compounding Pharmacy and Regulatory Agencies
Estimated proposal PF: Pharmacopeial Forum 44(4) [July–August 2018] 

Background and objective(s): With the retirement of the 1987 “Guideline on Validation of the Limulus Amebocyte Lysate Test as an end-Product endotoxin test for Human and animal parenteral drugs, biological products and medical devices in 2012, stakeholders have lost a lot of useful guidance on a variety of issues related to Bacterial Endotoxins Test which is a critical requirement for injectable products and medical devices required to be pyrogen free. The objective is to fill this critical gap in guidance with updated best practice. 

Description of scope and application: This proposed general information chapter will provide guidelines on Bacterial Endotoxins Test relative to but not limited to: control standard endotoxins, control of standard curves, analyst training and qualification, calculation of endotoxin limits for ingredients, drug products with single and multiple active ingredients and resolution of out-of-specification results.

Contact: Radhakrishna Tirumalai, Ph.D., Principal Scientific Liaison, General Chapters-Compendial Science, (301- 816-8339,