Endotoxin Reference Standard for LAL test

The Reference Standard Endotoxins RSE and BRP, produced to standardize and ensure uniformity in the LAL test, are released by USP and EP, respectively.

The typical format is 11,000–10,000 EU per vial, and they are used to set up the LAL test with any lysate lot.

 

Reference Endotoxins (RSE and BRP)

  • Composed of purified LPS
  • 10,000 EU/vial (BRP)
  • 11,000 EU/vial (RSE)
  • 1 EU = 1 IU

 

Applications of RSE and BRP

  • Standardize and ensure uniformity of the LAL test
  • The FDA requires LAL manufacturers to establish lysate sensitivity using an assay with a series of RSE dilutions
  • Primary standards to determine the potency of the CSE with a specific lysate
  • When a reference test is needed to resolve a disagreement
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