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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
2018 Sep;165(5):621-624
That includes COA availability, identity documentation, purity reporting, analytical testing, lot traceability, batch-specific records, and RUO labeling
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(30ml / 1.05FL OZ.)
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