ICP analysis (ICP-MS / AAS / AES).

For compliance with ICH Q3D guidelines and proof of freedom from harmful elemental impurities.

Do you want to ensure that your products do not contain elemental impurities above the permissible limits? The determination of elemental impurities is one of the key requirements of the ICH Q3D guidelines and is therefore an indispensable part of pharmaceutical quality control. Even small amounts of heavy metals or toxic elements can compromise the safety of a drug and have regulatory consequences.

Our ICP analyses combine state-of-the-art technologies with in-depth methodological expertise. We reliably analyze a wide range of elements—from arsenic and lead to mercury and cadmium—and deliver results that are both accurate and documented in accordance with audit requirements.

Our services at a glance:

  • ICP-MS and AAS/AES: High-precision methods for determining elemental impurities, suitable for a wide variety of matrices such as active ingredients, excipients, or finished drugs.
  • Method development and validation: Strong expertise in adapting, developing, and validating new methods in accordance with international guidelines. This ensures that even complex samples can be reliably analyzed.
  • Modern digestion technology: Use of Turbowave digestion for maximum accuracy and repeatability—even with challenging sample matrices.
  • Efficient analysis: Precise results even with very small amounts of substance, allowing even limited samples to be examined efficiently.

Our analyses not only provide you with certainty for regulatory submissions, but also valuable information for process optimization.

Your advantage: With CUP Contract Labs, you can ensure compliance with ICH Q3D limits and receive precise, GMP-compliant analyses—for greater quality, safety, and regulatory compliance.

customer voices

We highly appreciate our cooperation with CUP Contract Labs, thanks to their customer-oriented processes, agile handling of analysis requests, and support through tight deadlines. Their well-trained personnel tackles difficult and new problem sets with state-of-the-art equipment and a willingness to adopt new techniques.

Maria Carmen Visus-Miguel, Senior Director R&D at AOP Health, values CUP’s agile analytics support and adoption of innovative techniques

Maria Carmen Visus-Miguel, Senior Director R&D Operations

at AOP Health

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