Elemental Impurity Test

Understanding of Elemental Impurity

Elemental impurity testing is a service aimed at detecting minute traces of elemental impurities in pharmaceuticals. These impurities can stem from metal catalysts used in the manufacturing process or substances inadvertently introduced during assembly line production, storage, and packaging.

Several authoritative bodies like the International Committee for Harmonization (ICH), the U.S. Food and Drug Administration (FDA), and the United States Pharmacopeia (USP) have issued guidelines and restrictions concerning elemental impurities in products.

ICH classifies elemental impurities into four categories based on their PDE (Permitted Daily Exposure), which refers to the maximum acceptable daily intake of impurities in drugs.

Fig.1 ICH elemental impurities classification

Services Process

Sample collection and demand analysis

During this phase, we will engage with clients to understand the specific properties of the samples and inquire about the possible impurity that may be present. This information helps us tailor our initial testing to target the suspected impurities effectively.

Analysis

Based on the properties of the sample and the characteristics of impurities present, we select different analytical methods to ensure the most accurate and reliable testing results.

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

In short, we carefully select appropriate analytical methods based on the specific nature of the sample and customer requirements to ensure that our testing meets the highest standards of accuracy and reliability.

Data Analysis and Reporting

Our experienced analytical chemists will analyze the data obtained from the testing. We provide clients with a comprehensive report detailing the presence and concentration of elemental impurities in the samples.

The report will also include information on whether the detected impurities fall within regulatory limits and guidelines.

Consultation and Guidance

If the analysis reveals any concerns or if the clients have questions about the results, our experts will be available for consultation.

Protheragen-ING offers comprehensive Elemental Impurity Testing services to help you ensure the safety and compliance of your pharmaceutical products.

If you have any further questions, please contact us, and we will respond promptly to assist you within 2-4 working days.