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PDE values are based on the toxicological properties and  pharmacology of  the specific active  pharmaceutical ingredient (API).

 Determination of a PDE involves:


  • Hazard Identification by reviewing all relevant data.

  • Identification of 'critical effects'.

  • Determination of the no-observed-adverse-effect level ( NOAEL ) of the findings that are considered to be critical effects.

  • Use of several adjustment factors to account for various uncertainties.



 PDE (mg/day)=   NOAEL (mg/kg/day) X body weight (kg)

                                     F1X F2 X F3 X F4 X F5

 Reports are prepared by an scientific expert team and reports will be  approved by  DATB  certified  toxicologist




  • ICH Topic Q3C (R4). Impurities: Guideline for Residual Solvents (CPMP/ICH/283/95)

  • VICH GL18 (R): Impurities: Residual solvents in new veterinary medicinal products, active substances and excipients (EMA/CVMP/VICH/502/99-Rev.1).

  • ICH Q3D. Elemental Impurities. (Sept.2015)

PDE version anglaise(2).png

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