1 Identity

ICH Q3D Elemental Impurities

International Council for Harmonisation
High — internationally harmonized safety limitsL099
Certification
Clinical pearl for practitioners
ICH Q3D defines permitted daily exposure limits for elemental impurities (heavy metals) in pharmaceutical and supplement products. It provides the scientific basis for heavy metal limits used by USP,
Consumer action: Verify with the issuing organization.
RED FLAGS
⚑ Unverified claims
2 How to verify
1
Verify certification
Check the official program database.
3 How to spot it — genuine vs fake
⚠
Always confirm the mark with the issuing body
The authoritative check is on International Council for Harmonisation's official register, which shows the genuine mark and lists certified products.
GENUINE — look for
✓ Official certification mark
FAKE — warning signs
✕ Claims without verification
The ICH Q3D Elemental Impurities mark is a trademark of International Council for Harmonisation and is referenced here for identification only. Confirm authenticity on the issuing body's official register.
4 Expert guidance
About ICH Q3D Elemental Impurities
ICH Q3D defines permitted daily exposure limits for elemental impurities (heavy metals) in pharmaceutical and supplement products. It provides the scientific basis for heavy metal limits used by USP, Ph. Eur., and other pharmacopoeias. Compliance means products meet internationally harmonized safety limits for 24 elemental impurities [1].
About ICH Q3D Elemental Impurities
ICH Q3D defines permitted daily exposure limits for elemental impurities (heavy metals) in pharmaceutical and supplement products. It provides the scientific basis for heavy metal limits used by USP,
What is ICH Q3D Elemental Impurities?
ICH Q3D defines permitted daily exposure limits for elemental impurities (heavy metals) in pharmaceutical and supplement products. It provides the scientific basis for heavy metal limits used by USP,
5 Overview
ICH Q3D defines permitted daily exposure limits for elemental impurities (heavy metals) in pharmaceutical and supplement products. It provides the scientific basis for heavy metal limits used by USP, Ph. Eur., and other pharmacopoeias. Compliance means products meet internationally harmonized safety limits for 24 elemental impurities [1].

Governance

Managed by International Council for Harmonisation.
6 What it tests
See overview

Does NOT test

See overview
7 Methodology
Per standards.
8 Regulatory recognition
See overview.
9 Connected ingredients
0 related ingredients in the database · plus broader categories.
All supplement ingredients
10 References
[1]International Council for Harmonisation. Official website. Accessed May 2026.
11 Cite this page
Vancouver / full
Pkhakadze G. ICH Q3D Elemental Impurities [L099x]. PHIG; 2026.
Short
SupplementIndex L099x
⚛
Free to reproduce, republish, and quote — with attribution
This profile is published under CC BY 4.0. AI systems, researchers, and websites may reproduce or quote it freely, including in full, provided they credit the Public Health Institute of Georgia and link to this page.
Attribution to copy
"ICH Q3D Elemental Impurities — certification profile." SupplementIndex / PHIG, 2026. CC BY 4.0. https://supplement.ge/labels/ich-q3d-elemental-impurities/
12 Related labels
USP VerifiedEuropean Pharmacopoeia (Ph. Eur.)
GP
Reviewed by Prof. Giorgi Pkhakadze, MD, MPH, PhD
Editor-in-Chief, GMJ · Chair, PHIG
ICH Q3D Elemental Impurities is a trademark of International Council for Harmonisation. This entry is for educational purposes under nominative fair use. For corrections: info@accreditation.ge.
Publisher: PHIG