Elemental Impurities Calculator (ICH Q3D)
Get the ICH Q3D permitted concentrations of all 24 elements for your route and daily intake, and check measured levels against the PDE and the 30% control threshold.
- ICH Q3D(R2)
- All 24 elements
- Option 1 and 2a
- No sign-up
Four steps, or fewer
- Choose the route of administration.
- Keep 10 g/day for Option 1 limits, or enter the real maximum daily intake of the drug product for Option 2a.
- Optionally enter measured or expected levels by element symbol to see the % of PDE.
Not sure what to enter? Press Load example to see the calculator with realistic data. Your inputs are saved in this browser, so they are still there when you come back.
How the limits are derived
Control threshold = 30% of the PDE
Option 1 applies common limits to every component, based on a daily intake of 10 g. Option 2a uses the real daily intake. If the elemental impurity level is consistently below 30% of the PDE, no additional controls are required.
Which elements to assess
Class 1 (As, Cd, Hg, Pb) and Class 2A (Co, Ni, V) must always be considered. Class 2B elements only need assessment when intentionally added, for example as catalysts. Class 3 elements are considered for parenteral and inhalation products according to ICH Q3D Table 5.1. Any intentionally added element must be assessed.
The PDEs used here are from ICH Q3D(R2) Table A.2.1 for oral, parenteral and inhalation routes. Cutaneous and transcutaneous limits (Appendix 5) are not included.
References
- ICH Q3D(R2) Guideline for elemental impurities
- USP General Chapters <232> and <233>
These calculators are decision support for orientation and training. They are not validated GMP software, and results must be checked against your approved method, SOP and the current pharmacopoeia or guideline before use in GMP records. Your data is processed in your browser and is not sent to Molgenium.