Genotoxic Impurity Test

Understanding of Genotoxic Impurity

Genotoxic Impurities are substances with the capacity to harm genetic information within cells, leading to gene mutations, chromosome damage, and rearrangement.

As per the guidelines established by the International Council for Harmonization (ICH), stringent control of genotoxic impurities at minimal levels, often measured in parts per million (ppm), is imperative. This rigorous control is fundamental in ensuring the safety and quality of pharmaceuticals.

The Genotoxic Impurity Test holds immense significance in drug development, and registration processes, and stands as a critical inspection criterion for regulatory authorities overseeing drug production.

Technologies for Known Genotoxic Substances

For potentially known genotoxic substances within products, such as 1,4-dioxane (assessed following the European Union Risk Assessment Report, EU RAR), we employ a range of advanced technologies to ensure both quantitative and qualitative detection.

These cutting-edge techniques include High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Mass Spectrometry (MS), Nuclear Magnetic Resonance (NMR), and more.

Services Process

Sample Collection and Consultation

Our experts engage with clients to understand their specific needs and project objectives. We inquire about the possible impurities clients are concerned with, assisting us in targeting the suspected impurities effectively.

Sample Preparation and Analysis

Our experienced team meticulously prepares samples for testing to ensure accurate detection. Depending on the sample properties and the characteristics of impurities present, we select different analytical methods for the most accurate and reliable results.

• For impurities that dissolve readily in solution, we typically use techniques such as HPLC and LC-MS.
• For impurities that do not dissolve and are mixed into the product, we employ a variety of analytical techniques to identify and analyze these impurities. Techniques like X-ray Diffraction (XRD), Inductively Coupled Plasma Atomic Emission Spectroscopy (ICP-AES), and Infrared Spectrometry (IR) come into play.

Data Analysis and Reporting

Our experienced analytical chemists meticulously analyze the data obtained from the testing process. Then we provide a professional report that details the presence and concentration of elemental impurities in your samples. The report also provides information on whether the detected impurities fall within regulatory limits and guidelines.

Consultation and Guidance

Our experts are available to address any concerns or questions that may arise from the analysis results after the delivery of the final report.

Protheragen-ING is committed to providing clients with the insights and services needed to ensure the safety and compliance of pharmaceutical products. If you have further inquiries or require more information, please do not hesitate to contact us.