Elemental impurity analysis

Instrument-based analysis of elemental impurities is a more specific way to test drugs for potentially toxic constituents. According to the requirements of drug regulatory authorities, the use of new, specific and sensitive measuring devices is essential. Drug manufacturers and raw material suppliers have been required to perform elemental impurities risk analysis and control (according to ICH Q3D "Guideline for elemental impurities") since June 2016 (Europe) and December 2017 (USA) when submitting new drug applications.

Specifically, this means that the analysis of heavy metal contamination has been changed from the previous non-specific method to a specific analysis of elemental impurities.

We offer complete development, validation and testing procedures with cGMP compliant documentation to prove all tests we perform. With our expert staff and superbly equipped, state-of-the-art laboratories, we can help you meet the requirements with ease.

How we test for elemental impurities

We help you understand and meet the requirements of EP, USP and ICH Q3D
We'll guide you through the entire testing process, from determining the limits to determining the elements present
Together, we decide whether you need quantitative or qualitative testing
Our experts will help you decide whether you should have your active pharmaceutical ingredient or finished drug product tested
Based on the available data, we jointly determine which impurities should be tested for and with which limits
We offer you the choice between a fully validated or risk-based approach to testing for elemental impurities
We support you in performing a solid risk assessment if further data is missing

Our experts have the technical expertise and regulatory qualifications required for method development, method validation, and routine testing. We have extensive experience with all methods included in the regulations and are ready to implement these new test methods.

Our highly qualified staff is always up to date with regard to the constantly changing requirements.

Our offer

Modern, qualified equipment including ICP-MS, ICP-OES, flame/graphite tube AAS, hydride generator AAS.
Microwave pressure digestion for sample preparation, also possible with HF
Experience with elimination of physical, chemical, spectral, isobaric and polyatomic interferences
Many years of experience with method development and validation
Many years of experience with the verification of pharmacopoeial methods
Experience with a wide range of sample types and complex sample matrices

Our services also include customized processing of your samples to meet the requirements of pharmaceutical elemental analysis, based on a sound understanding of the ICH Q3D guideline.

Numerous validations and method implementations - tailored to the specific requirements resulting from matrix, dosage form and manufacturing characteristics, among others - have already been successfully carried out.

Want to learn how our experience with elemental impurities can help you meet regulatory requirements? Contact us today.

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