Inorganic Impurity Test

Understanding of Inorganic Impurities

Inorganic impurities are compounds found in products and can include various substances such as metals, minerals, salts, oxides, sulfur compounds, and more. Unlike organic impurities, inorganic impurities are often known compounds.

They can originate from various sources, including manufacturing processes that use metal catalysts, inorganic salts in chemical reactions, and the introduction of excipients during production, like chromatographic column packing (such as silica gel), filter aids (diatomaceous earth), and decolorizing agents (activated carbon).

These inorganic impurities have the potential to negatively impact human health or reduce product quality and potency. Hence, it is crucial to monitor and control them.

The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines mandate that the specification for a new drug should list each identified inorganic impurity, specify unknown impurities, and set acceptance criteria for unspecified impurities not exceeding the identification threshold, as well as the total impurities.

Services at Protheragen-ING

Sample Analysis & Project Planning

We initiate by conducting an in-depth analysis of clients specific needs and project objectives. Understanding the impurities to target is basic.

After the requirement assessment, we craft a tailored project plan. This plan includes details on the analytical methods, instruments, and the timeline of your project.

Sample Preparation

Our expert team meticulously prepares your samples. Depending on the sample type and impurities of concern, we employ various techniques and specialized instruments. This ensures that impurities are expertly concentrated for accurate detection.

Analysis

Our laboratory employs an array of analytical techniques to assess inorganic impurities. This may include methods like ash content determination and ion chromatography for quantitative testing, XRD (X-ray crystallography), SEM (scanning electron microscopy), TEM (transmission electron microscopy), X-ray crystallography, and microscopy for qualitative testing.

Report Submission

Following the analysis, we compile a professional report. This report provides measurement values, qualitative results from impurity analysis, and any quantitative findings, equipping you with the information necessary for informed decisions.

Ongoing Support

Our services extend beyond the delivery of the final report. We are available to address any questions or concerns clients may have after receiving the results.

We are dedicated to ensuring that our services meet your specific needs and provide the insights required to make informed decisions. If you have any questions or need further information, please feel free to contact us. Protheragen-ING is here to support your success.