Impurity Test

As it assists in identifying and quantifying any impurities in an active pharmaceutical ingredient (API) or pharmaceutical formulation, impurity testing is a crucial component of drug analysis. These contaminants may arise from a number of processes, such as the production procedure, API deterioration, or interactions with packaging materials.

Protheragen-ING specializes in providing the pharmaceutical industry with drug impurity testing for new APIs and new drug products. We can support your product development and help you ensure the safety and efficacy of your drug product by detecting and characterizing impurities from the early stages and throughout the entire phase.

Impurity Test

Scope of Impurity Testing Services

In order to achieve accurate and exact impurity analysis, Protheragen-ING works closely with clients to understand their unique demands and design analytical methods for impurity testing that comply with regulatory guidelines.

Protheragen-ING analyzes and characterizes impurities using a range of analytical techniques.

We can offer comprehensive information on the kind and composition of contaminants found in pharmaceutical items because we have a great deal of experience analyzing complex data.

Accurate quantification of contaminants is crucial in evaluating the security and caliber of medicinal items.

Modern equipment and tried-and-true techniques from Protheragen-ING measure contaminants at trace levels, guaranteeing regulatory compliance and giving you trustworthy data for stability testing and product launch.

To determine the possible effects of impurities on product quality and patient safety, Protheragen-ING provides thorough impurity analysis and risk assessment services.

Impurities, such as genotoxic and mutagenic impurities, can be thoroughly analyzed by us in order to evaluate any potential dangers and choose the best course of action for control.

Testing Available

Protheragen-ING ensures the safety and quality of your pharmaceutical products through our comprehensive impurity testing capabilities. If you need analysis and identification of other impurities, please contact our technical staff.

Analytical Techniques for Impurity Identification

Chromatography- HPLC, LC/MS, GC/MS, GC/FID, GC/TCD, GPC/SEC.
Microscopy- AFM, SEM, TEM, STM, LSCM.
Spectroscopy- UV-Vis, FTIR, Raman, NMR, ICP-MS, MS, PXRD, TF-XRD.
Others- DSC, TGA, TOC, BET specific surface area/porosity analyzer.

Analytical Techniques for Impurity Identification

Our Strengths

Contact us today to discuss the specific requirements of your impurity testing services and learn how we can help you meet your regulatory obligations and maintain product excellence. We will respond within 2-4 working days.


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