Sufentanil
Summary
Persistence. It cannot be excluded that sufentanil is persistent, due to lack of data.
Bioaccumulation. Sufentanil has low potential for bioaccumulation.
Toxicity. It cannot be excluded that sufentanil is toxic, due to lack of data.
Risk. Risk of environmental impact of sufentanil cannot be excluded, due to the lack of environmental toxicity data.
This summary information for sufentanil comes from assessment report (2018) and fass.se.
Detailed information
Assessment report
Assessment report for Dzuveo (sufentanil), FGK Representative Service GmbH, 26 April 2018, EMA/302958/2018.
Hazard
Persistence:
Bioaccumulation: Log Kow = 3.24.
Toxicity: No data.
Risk
PEC in the assessment report from a European perspective:
PEC = 0.0036 microg/L. > 0.01 threshold (N).
Sufentanil has only undergone a phase I study in accordance with regulatory requirements for environmental risk assessments (Guideline on the environmental risk assessment of medicinal products for human use, EMEA/CHMP/SWP/4447/00 Rev. 1- Corr.) A phase I study includes data on bioaccumulation and an estimation of the environmental concentration of sufentanil (PECSurface water). If the specified threshold values are not exceeded, the company is not required to conduct a Phase II study, which includes data on toxicity, persistence, and risk assessment based on PEC/PNEC.
Fass environmental information
Fass environmental information for Sufentanil hameln from hameln pharma (retrieved on 2026-06-16).
Excretion (metabolism)
"Biotransformation of the substance occurs primarily in the liver and small intestine. Nearly 80% of the dose administered is eliminated within 24 hours, with only 2% in the form of the unchanged substance."
Hazard
Persistence: No data.
Bioaccumulation: "Log Pow = 3.45 (experimental by shake flask method). Since log Log P < 4, the substance has low potential for bioaccumulation."
Toxicity: No data.
Risk
PEC/PNEC is based on total sold amount API (active pharmaceutical ingredient) in Sweden year 2024.
PEC = 2.192*10-7 microg/L.
Risk (PEC/PNEC) of environmental impact of sufentanil cannot be excluded, due to the lack of environmental toxicity data. However, according to the European Medicines Agency guideline on environmental risk assessment of medicinal products (EMA/CHMP/SWP/4447/00), use of sufentanil is unlikely to represent a risk for the environment, because the predicted environmental concentration (PEC) is below the action limit 0.01 microg/L."
Author: Health and Medical Care Administration, Region Stockholm