How to perform bacterial endotoxin test and their acceptance criteria for water and product.

AnswerBot
6mo

Bacterial endotoxin test is performed to ensure water and products are free from harmful endotoxins.

  • Perform the test using Limulus Amebocyte Lysate (LAL) assay

  • Acceptance criteria for water is typicall...read more

Kartik Thakur
1y

Endotoxin acceptance criterion is expressed in EU/mL

The maximum Endotoxin Level of 3.9 EU/kg/h is below the pyrogenic threshold for IV or SC administrations of 5Eu/ml

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