Know what’s inside:

Elemental Impurities Testing

GBA Pharma Labs - Elemental Impurities Testing

Impurities: Guideline for Elemental Impurities

The ICH Guideline Q3D "Impurities: Guideline for Elemental Impurities" provides an international standard for testing for metals in the member regions, Europe, USA, and Japan.

These guidelines for the determination of heavy metals have been integrated into the American Pharmacopeia (USP/NF) in chapters <232> and <233>. For the European Pharmacopeia (Ph.Eur.), these guidelines appear in chapters 5.20 "Elemental impurities" and 2.4.20 "Determination of elemental impurities."

The previously used visual test from the corresponding pharmacopeias (e.g. USP <231>, Ph.Eur. 2.4.8) has thus been replaced by modern methods using instruments such as the ICP-MS and/or ICP-OES.

In Ph.Eur. 9.3 (published on July 1st 2017) ICH Q3D is now adopted within the chapters "Pharmaceutical preparations" and "Substances for pharmaceutical use".

There is a new paragraph "Elemental impurities" in the chapter "Pharmaceutical preparations":

"For pharmaceutical preparations outside the scope of the general chapter 5.20, manufacturers of these products remain responsible for controlling the levels of elemental impurities using the principles of risk management."

This means that for products outside the scope of ICH Q3D like herbal products etc. the marketing authorization holder (MAH) remains responsible for any possible input of elemental impurities due to production processes, containers or excipients!

The Ph.Eur. monograph "Substances for pharmaceutical use" still excludes herbal drugs, herbal drug preparations and homeopathic mother tinctures from this scope.

This leads to the phenomenon that the MAHs on the contradictory have to establish risk assessments for their products in the end too to fulfill their responsibility!

The GBA Group will gladly help you adapt to fulfill the new requirements by consulting, compilation of risk assessments, as well as analytical tests.

Using our modern ICP-OES and ICP-MS systems, we offer the following analytical services:

  • Quantitative and Qualitative Testing for Heavy Metals
  • Method Development and Validation
  • System-Specific Tests
  • The Determination of Individual Acceptance Criteria for Your Product

The experienced and highly committed GBA Pharma Labs team offers a variety of different services in the following Areas.

GBA Pharma Labs - GMP Testing

GBA Pharma Labs – GMP Testing

GBA Pharma Labs - GMP Quality Control

GMP Quality Control

GBA Pharma Labs - Method Development & Validation

Method Development & Validation

GBA Pharma Labs - Stability Studies

Stability Studies

GBA Pharma Labs - Dissolution


GBA Pharma Labs - Extractables & Leachables

Extractables & Leachables

GBA Pharma Labs - Packaging Material Testing

Packaging Material Testing

GBA Pharma Labs - Particle Determination

Particle Determination

GBA Pharma Labs - Elemental Impurities Testing

Elemental Impurities Testing

GBA Pharma Labs - Microbiology


GBA Pharma Labs - Regulatory Services

Regulatory Services

GBA Pharma Labs - Amino Acid Analysis

Amino Acid Analysis

GBA Pharma Labs - Instrumentation


GBA Pharma Labs - N-nitrosamines


GBA Pharma Labs - qPCR


GBA Pharma Labs - iCEF


GBA Pharma Labs - Protein characterization

Protein Characterization

GBA Pharma Labs - Limit test for DEG and EG by GC

Limit test for DEG and EG by GC

GMP Testing

Contact us!

To learn more about us and what we can do for you please contact us.

Contact form
Contact form


Do you have any questions about our service?

Contact form
© 2024 GBA Group

Follow Us

  • linkedIn GBA Pharma
  • xing
  • GBA youtube
  • gba Instagram
ContactData PrivacyLegal NoticeTerms & ConditionsDisclosure
Phone Phone