PDA Technical Glossary
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PDA Technical Glossary

PDA Technical Reports are highly valued membership benefits because they offer expert guidance and opinions on important scientific and regulatory topics and are used as essential references by industry and regulatory authorities around the world. These reports include terms which explain the material and enhance the reader’s understanding.

The database presented here includes the glossary terms from all current technical reports. The database is searchable by keyword, topic, or by technical report. Each definition provided includes a link to the source technical report within the  PDA Technical Report Portal.

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TR 82: Low Endotoxin Recovery Microbiology
Activity
Ability of endotoxin (LPS) to initiate the LAL cascade in the compendial bacterial endotoxins test (BET) assay, or the ability to elicit a pyrogenic response in a compendial pyrogen test (2,10). Activity can be measured by other assays such as the monocyte activation test (MAT) or recombinant Factor C tests (rFc), if such tests have been validated, to demonstrate that decisions made from the results are comparable to or superior to the compendial assay. Activity is measured in endotoxin units (EU). In terms of activity, one EU = one IU, regardless of the source. Activity is generally expressed as a concentration, usually EU/mL.(TR82)
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Lipopolysaccharide
A component of the cell wall of Gram-negative bacteria.(TR3) Component of the outer cell wall of Gram-negative bacteria that is pyrogenic. (TR69)(TR82)
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Low Endotoxin Recovery (LER)
The inability to recover ≥50% activity over time when known amount of endotoxin is added to an undiluted product. LER cannot be overcome by dilution.(TR82)
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Masking
A type of interference that may result in low endotoxin recovery.(TR82)
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Nominal Value
The assumed activity of an endotoxin preparation, dilution, or "spike"; based on label-claim information.(TR82)
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Reference Standard Endotoxin (RSE)
The primary standard from USP, EDQM, JP and WHO for use in the harmonized compendial bacterial endotoxins test (BET). The current 3rd International Standard (WHO), USP, and EDQM RS are lyophilized formulation that contains highly purified LPS that is chemically extracted and purified from E. coli strain O113:H10:K(-) and further formulated with stabilizers and excipients.(TR82)
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