Study of leachables in a nasal spray solution

Nose and ear sprays fall under the category of health products . As such, they are subject to the same regulations as medical devices. Thus the use of a plastic bottle to contain the product requires a study of leachables to confirm the absence of migration and of undesirable compounds.

Study of leachables on a 100% natural seawater spray packaged in a PP bottle

The diffusion of matter from the container to the contents is an irreversible transport phenomenon which results in the migration of chemical species. Depending on the type of polymer, its formulation, the diffusion will not be the same. Low molecular weight molecules have a higher diffusion than high molecular weight ones.
The study of leachables therefore involves a very broad scan of possible contaminants. A comparison between a formulation without contact with the packaging (= analytical blank) and a formulation after contact is essential.