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.

Relargable spray

Study protocol set up by thePOLYMEX laboratory

  • Preparation of the sample if necessary to obtain a matrix compatible with the analysis
  • Identification and determination of volatile organic compounds according to ISO 10993-18 (nonionic, 100 <Mw <650 g / mol) by GCMS
  • Identification and determination of non-volatile organic compounds by UPLC / TOF-MS in APCI / ESI mode according to ISO 10993-18.
  • Phased array elemental analysis (28 elements) according to ISO 10993-18 for identification of inorganic or semi-organic compounds.
  • Analysis of a pack of 10 anions according to ISO 10993-18 by ion chromatography.

Thanks to this study => Demonstration of molecules resulting from the migration of leachable compounds

Contact us to jointly process your request for a study of extractable and leachable substances in order to confirm that your materials are suitable for the desired use.

Other examples from the health sector:

Study of leachables - Identification and determination of volatile organic compounds according to ISO 10993-18 (nonionic, 100 <Mw <650..
Stydy of leachable in nasal spray

Stydy of leachable in nasal spray

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Identification of pollution in a medical bag

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Study of extractable and leachable compounds

Study of extractable and leachable compounds