Hello, I am trying to validate an endotoxin method for an excipient. I need to calculate my endotoxin limit. My excipient is 0.1% final product and the drug concentration is expressed in vp/mL. I have a drug spec of 18EU/0.5x10^11vp and a conc. of 0.8x10^11vp/mL. I am struggling to determine how to calculate what the limit would be for the excipient.
Any suggestions?