Quality
Control
At AMSbiopharma, we provide specialized quality control services to ensure the safety and efficacy of pharmaceutical products. From drug impurity analysis to protein and nucleic acid-based biopharmaceutical testing, we use advanced techniques like UPLC-MS/MS and ICP-MS to meet the highest industry standards and regulatory requirements.
ICP-MS Analysis
At AMSbiopharma, we offer our customers a high quality service in the development and validation of methods for the analysis of final products, intermediates, APIs and excipients. Using ICP-MS (Inductively Coupled Plasma Mass Spectrometry) analysis, we provide comprehensive validation studies covering parameters such as specificity, accuracy, precision, linearity and robustness, ensuring the reliability of analytical procedures.
AMSbiopharma performs stability and validation studies at every stage, from raw materials to finished products, to ensure consistent quality throughout the manufacturing process.
- Analytical Development: Our team of experts uses the most advanced technologies and methodologies, such as ICP-MS analysis, to design analytical studies tailored to the specific needs of each client. From characterization of active ingredients to quantification of impurities, our meticulous approach ensures robust and reproducible methods.
- Analytical Validation: Confidence in results is essential. That is why at AMSbiopharma we not only develop, but also validate our analytical methods according to the strictest international standards. Our validation protocols are designed to demonstrate the reliability and consistency of results, ensuring that each product meets the required quality and safety standards.
Related Services
ICP-MS analysis
Development and validation of methods by ICP-MS
Determination of the level of Elemental Impurities (ICH Q3D, USP <232> and <233>, EP (5:20) and (2.4.20))
Determination of the concentration of Contaminant Metals (Medicines, Food Supplements, Foodstuffs and packaging materials)