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Just Released! White Paper: Measuring Autochthonous Endotoxin Levels in Parenteral Products


Pharmaceutical companies often rely on internal water systems to deliver filtered, endotoxin-free water for product manufacturing. When these water systems fail, they can introduce autochthonous (formed or originating in the place where found) endotoxin into intermediates or products.


Our new White Paper features a study in which four parenteral products, each spiked with a water sample containing a known amount of autochthonous endotoxin, were tested for endotoxin by a contract testing lab using a kinetic turbidimetric method, kinetic chromogenic method, and two rFC methods (one of which was the PyroGene® rFC Assay). This White Paper includes the results of this study and showcases how the PyroGene® rFC Assay can detect autochthonous endotoxin in a comparable fashion to the LAL-based methods.


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New Presentations Available in the Library!


New tools include:


  • Endotoxin Testing for Biologics
  • Vaccine Safety: Pyrogen and Endotoxin Testing
  • “Error-proofing” and “Future-proofing” a Compliant Bacterial Endotoxins Test
  • Endotoxin Detection – Which Method is Best for Me?

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