#impuritytesting

[pharmaceuticalresearch]

High-Purity Diazinon Impurities Standards from SynZeal for Reliable Drug Development | SZ-D140001

SynZeal’s Diazinon impurity standards ensure the precision and consistency needed for R&D, regulatory compliance, and quality control of organophosphate insecticide formulations.

[eurofinsadvinus]

Wondering if your drug product has leachable impurities above analytical evaluation threshold (AET)? Perform safety assessment for the concerned leachable impurities with us. We design studies to meet the guidelines of regulatory bodies across the world. Partner with us for your testing requirements. Contact us today - bd@advinus.eurofinsasia.com To know more click here 👉 https://lnkd.in/dmyhERPR

[pharmaceuticalresearch]

High-Purity Denosumab Impurities Standards from SynZeal for Reliable Drug Development | SZ-D185001

SynZeal’s Denosumab impurity standards support accurate R&D, quality control, and regulatory compliance for monoclonal antibody-based osteoporosis treatments.

[eurofinsadvinus]

Contact us to book elemental impurity analysis in your drug formulations. Our team is up-to-date with the current global regulatory standards for permitted levels of trace metals. Their expertise coupled with our state-of-the-art instruments ensures we provide you with accurate, high quality results. Impurities can lead to delays in development. It is essential to evaluate pharmaceutical products for high concentration of elemental impurities - trace metal/heavy metal testing of elements such as lead and arsenic that are significant toxicological concern. The FDA and ICH provide recommendations for testing impurities and acceptable impurity limits.

[eurofinsadvinus]

Did you know Nitrosamine compounds are potent genotoxic agents in several animal species and some are classified as possible human carcinogens by the International Agency for Research on Cancer (IARC)? The team at Eurofins Advinus is here to help you test your APIs and drug products for nitrosamine impurities. Click on the link to schedule a call with our experts - https://lnkd.in/eDKB93N The discovery of nitrosamines in some types of drug products led FDA and other international regulators to conduct a detailed analysis of these impurities in affected APIs and drug products. Based on the Agency’s current understanding, API and drug product manufacturers are advised to (1) conduct risk assessments of their approved or marketed products and products with pending applications, and (2) take appropriate actions to reduce or prevent the presence of nitrosamines in APIs and drug products. Although nitrosamine impurities have been found in only some drug products, and batches of those products have been recalled when there were unacceptable levels of these impurities, nitrosamine impurities might exist in other APIs and drug products due to use of vulnerable processes and materials that may produce nitrosamine impurities. Therefore, the recommendations made apply to all chemically synthesized APIs. They also apply to drug products containing chemically synthesized APIs and to drug products at risk due to other. Source: https://lnkd.in/gydBxuy

[eurofinsadvinus]

We provide Nitrosamine impurity testing under GMP requirements. Our facility is equipped with instruments to quantify ultra-low levels of these impurities. Connect with us at bd@advinus.com for more details.