Radhakrishna Tirumalai, Ph.D.

A Summary of USP’s Workshop on “The Future of Endotoxins and Pyrogen Testing: Reference Standards and Procedures”
Wednesday, October 30, 2019
All parenteral articles and medical devices that contact body tissue or fluids have to be sterile and pyrogen free. A standard method that utilizes increase in body temperature of rabbits to detect acceptable level of ... read more
USP <1228.x>; An Evolving Series of Informational Chapters on Depyrogenation
Friday, February 16, 2018
The first mention of depyrogenation in the United States Pharmacopeia can be traced back to an informational chapter that appeared in the Fifth Supplement to USP 20-NF 15 entitled, “Sterilization and Sterility Assurance of ... read more
Naturally Occurring Endotoxin: A New Reference Material Proposed By the US Pharmacopeia
Friday, July 29, 2016
In response to stakeholder requests, USP (US Pharmacopeial Convention; www.usp.org) is proposing a new reference standard, Naturally Occurring Endotoxin (NOE), to be prepared from cell wall extracts of a well characterized... read more
USP Improves, Expands Standards Related to Microbial Contamination and Bioburden Control
Monday, June 18, 2012
While many contributing factors can play a role in affecting the quality of a medicine or its ingredients, microbial contamination control and issues related to sterilization must always be major considerations for any ... read more
Activities of the USP Microbiology and Sterility Assurance Expert Committee During the 2005–2010 Revision Cycle
Friday, July 01, 2011
This article is a comprehensive review of the published activities of the Microbiology and Sterility Assurance Expert Committee (MSA EC) of the United States Pharmacopeial Convention (USP) Council of Experts for the 2005–2010... read more

Radhakrishna Tirumalai, Ph.D.

Articles by Radhakrishna Tirumalai, Ph.D.

A Summary of USP’s Workshop on “The Future of Endotoxins and Pyrogen Testing: Reference Standards and Procedures”

USP <1228.x>; An Evolving Series of Informational Chapters on Depyrogenation

Naturally Occurring Endotoxin: A New Reference Material Proposed By the US Pharmacopeia

USP Improves, Expands Standards Related to Microbial Contamination and Bioburden Control

Activities of the USP Microbiology and Sterility Assurance Expert Committee During the 2005–2010 Revision Cycle

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