Eurofins Advinus has a team of experts who can help you choose the most suitable tests to identify impurities in your drug substance/product.
Impurity is any component of the new drug substance/product that is not the drug substance or an excipient in the drug product. Impurities may arise from a variety of sources -
- Manufacturing impurities can come from raw materials, active ingredients, excipients, process impurities and packaging impurities
- Leachable impurities are compounds that migrate into the formulation from the label, container components, or coatings of the container and closure system as a result of direct contact with the formulation
- Degradation impurities are formed from the breakdown of the drug substance or product, possibly due to storage conditions, interaction of ingredients from the container, label or closing systems, or treatment of the material
Knowledge gained from impurity qualification analysis can be used to guide formulation development and improve manufacturing and packaging processes.
Connect with Eurofins Advinus
- We understand the importance of proper analysis to be conducted for impurities
- We have more than 30 years of experience in conducting safety studies
- We have designed and reported more than 100 GLP impurity qualification studies for various class of drug substances and products
- If a Degradation products is detected in significant amounts, as per ICH guidelines, we can assist to identify, test for, and monitor the same against appropriately established acceptance criteria
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