Endotoxin Limits for Epidural Products in the New USP <797>

James Zellner, Technical Sales Representative

USP 797 states “CSPs administered epidurally should have the same endotoxin limit as that of intrathecally administered CSPs.” This new requirement lowers the endotoxin limit for epidural products from parenteral limit calculations to intrathecal limit calculations.

The difference between parenteral calculated limits and intrathecal/epidural limits is a factor of 25, i.e. a calculated endotoxin limit of 350 EU/mL for a parenteral preparation becomes 14 EU/mL when calculated for intrathecal/epidural administration.

Common Epidural medications include:

  • Bupivacaine
  • Ropivacaine
  • Lidocaine
  • Fentanyl
  • Sufentanil
  • Morphine
  • Hydromorphone

For more information about endotoxin testing or the changes coming in the new USP <797>, please contact ARL at 1-800-393-1595 or email info@arlok.com.