Organic Impurities

Pharmaceutical laboratories summarise actual and potential impurities that are most likely to arise during the synthesis, purification, and storage of the drug substance and excipients. The finished dosage forms summarize the degradation products observed during manufacture and stability studies of the drug product, including impurities arising from the interaction with excipients and/or the immediate container closure system.

All the studies conducted to characterize any impurity at a level greater than the identification threshold – in any batch manufactured by the proposed commercial process – should be identified. In addition, any degradation product observed in stability studies at recommended storage conditions at a level greater than the identification threshold should be identified to guarantee the safety of medicines.

We provide the tools and processes you need to take control of your organic impurities testing for drug substances, drug products, and excipients.