Extractables and leachables studies provide qualitative and quantitative data to build a comprehensive profile of extractable components.
ICH pharmaceutical stability studies are an essential component of the development and lifecycle of pharmaceutical products, in particular.
Elemental Impurities in drug products can arise from several sources, including interactions with processing equipment or container/closure systems.
Intravenous (IV) administration of many sterile drug products requires admixture preparation using a diluent, brief storage in an IV container, and dosing through an infusion device.
During transportation of pharmaceutical parenteral, ophthalmic and Inhalation products, it is not uncommon for them to encounter extreme temperature conditions.
Preventing moisture from permeating through the packaging is an important function of the container-closure system used for parenteral product, ophthalmic product.