Articles in this Issue

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  Will A Proposed Reduction in Endotoxin Limits for Drugs and Biologics Improve Patient Safety?

  Any parenteral therapy theoretically carries a risk of bacterial endotoxins contamination which can result in a number of physiological responses in humans, including fever. It is ... read more
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  Development and Qualification Factors for Endotoxin Removal from Proteins Using Chromatographic...

  Purification is a necessary phase in pharmaceutical drug manufacturing in order to eliminate unwanted materials that can be hazardous or which will compromise drug efficacy. This ... read more
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  Opinion: Reflections on Testing Medical Devices— Is it Time for an Update?

  There was a time when medical devices were largely pieces of extruded or molded plastic. In fact, until recently, the name of USP chapter describing pyrogen and endotoxin testing ... read more
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  An Interview with Veronika Wills - Manager, Technical Services Associates of Cape Cod, Inc.

  The methods that are currently defined in the harmonized Bacterial Endotoxins Testing (BET) chapters are all based on the use of animal derived lysates of amebocytes (either ... read more
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  European Pharmacopoeia Approach to Testing for Pyrogenicity

  The texts of the European Pharmacopoeia (Ph. Eur.) play a major role in ensuring the quality of medicines in Europe. They consist in general chapters and monographs, which are ... read more
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  The Truth of Endotoxin Values - Points for Consideration During Investigation of Aberrant BET...

  Bacterial Endotoxin Testing (BET) is mandatory for detection of Endotoxin/ Lipopolysaccharides (LPS) in parenteral drug products. This is important as LPS is one of the most potent... read more