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.
Scope of Impurity Testing Services
- Method Development and Validation
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.
- Identification and Characterization of Impurities
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.
- Quantitative Impurity Analysis
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.
- Impurity Analysis and Risk Assessment
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.
Our Strengths
- We have extensive knowledge and expertise in impurity testing and drug analysis to ensure accurate and reliable results.
- We are well versed in international regulatory requirements and can ensure that your products meet the necessary standards.
- Protheragen-ING's laboratories are equipped with state-of-the-art instrumentation and technology to provide accurate and timely results.
- We understand the importance of confidentiality in the pharmaceutical industry. Customer data and information are handled with the highest degree of confidentiality and security.
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.
