ICH guideline
ICH Q3D(R2): Guideline for Elemental Impurities
ICH guideline · Quality Guidelines · Step 5
Key facts
| ICH code | Q3D(R2) |
|---|---|
| Title | Guideline for Elemental Impurities |
| Guideline series | Quality Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | ICH Q3D(R2) Guideline for Elemental Impurities is a quality guideline for the control of elemental impurities in new drug products (medicinal products), and it establishes Permitted Daily Exposures (PDEs) for 24 Elemental Impurities (EIs) for drug products administered by the oral, parenteral and inhalation routes of… |
| File | Q3D(R2) Step 4 Presentation |
| File type | |
| File on ich.org | database.ich.org |
At a glance
- No Full text searchable in Orca1
- Q3D(R2) Step 4 Presentation Files published by ICH
- 1–9 FDA guidance documents based on this guideline
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About ICH guidelines
ICH guidelines harmonise the technical requirements for registering medicines in the ICH regions. Each guideline moves through a five-step process, from concept paper to adoption and implementation by regulators.