Peptide Endotoxin Calculator
Turn the endotoxin result on a Certificate of Analysis (COA) into EU per kg of body weight per hour, and see how it compares with the FDA/USP pyrogenic threshold of 5.0 EU/kg/hour for parenteral products.
The reference is per hour. 1 hour is the conservative choice for a single entry.
Enter the endotoxin value from the COA, the amount per vial, the amount per entry and body weight.
Based on the FDA/USP pyrogenic threshold of 5 EU/kg/hour for parenteral (IV, SC, IM) products. Endotoxin values come from the Certificate of Analysis (COA). This is arithmetic on your inputs. It doesn’t establish that anything is safe, and it isn’t medical advice.
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How the endotoxin math works
- EU per mg = EU per vial ÷ mg per vial (or use EU/mg straight from the COA).
- EU per dose = EU per mg × dose (mg).
- EU/kg = EU per dose ÷ body weight (kg). Divide by the number of hours for EU/kg/hr.
- The reference is K = 5.0 EU/kg/hour (USP <85>, FDA guidance for parenteral drugs).
- Example: 2.5 EU in a 5 mg vial is 0.5 EU/mg. A 0.25 mg dose is 0.125 EU. At 175 lb (79.4 kg) that's 0.0016 EU/kg/hr, about 0.03% of the threshold.
Frequently asked questions
What is an endotoxin unit (EU)?
An endotoxin unit measures biological activity of bacterial endotoxin, as measured by the LAL test. Labs report it on a COA, usually as EU/mg or EU per vial.
What is the 5 EU/kg/hr limit?
It's the pyrogenic threshold used by FDA and USP for parenteral (injected) products: no more than 5.0 EU per kg of body weight per hour. Intrathecal products use a much lower limit.
Where do I find the endotoxin value on a COA?
Look for a line such as "Endotoxin (LAL)" or "Bacterial endotoxins", reported in EU/mg or EU/vial. A result like "< 0.5 EU/mg" means below that level; entering 0.5 gives a cautious, upper-bound result.
Is a result under the threshold safe?
Not necessarily. This is arithmetic on the numbers you enter. It doesn't establish that a product is safe or sterile, and it isn't medical advice.