OINDP devices may contain polymers, elastomers and other components from which minute quantities of material may migrate/leach into product and enter the respiratory tract along with the therapeutic agent.
Among those leachables, nitrosamines, phthalates and poly aromatic hydrocarbons (PAH) were targeted in this study due to their toxicity and carcinogenicity at low concentration levels.
As a result, a highly sensitive method was developed for the quantitation of 40 leachables in OINDP products using the Shimadzu GCMS-TQ8040. The method can be used for screening of leachables in various pharmaceutical products.
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