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Regulatory agencies recommend the risk evaluation of all the packaging materials used for the storage of drug products. This includes all the primary, secondary as well as tertiary packaging materials.
Medical devices are also required to be evaluated for the potential risk assessment based on the chemical characterization.
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Chemical species that can be released from a pharmaceutical packaging/delivery system, packaging component, or packaging material and medical devices of construction under laboratory conditions including extraction solvent, technique, stoichiometry, temperature, and duration. Extractables themselves, and/or substances derived from extractables, have the potential to leach into a drug product formulation under normal conditions of storage and use.
Chemical species that migrate from a packaging/delivery system, packaging component, or packaging material of construction or medical devices into an associated drug product formulation under normal conditions of use or during accelerated drug product stability studies. Leachable are typically a subset of extractables or are derived from extractables.
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