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Leachables and Extractables Testing Every material in contact with the nasal spray drug product the HDPE bottle, the polypropylene pump housing, the elastomeric valve gaskets and seals, the actuator tip, and any metal spring components is a potential source of extractable compounds that may migrate into the drug product during manufacture, storage, and use

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JAMA Network Open, 6(4), e238707

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no large-scale controlled human clinical trials establishing safety or efficacy currently exist