Application Note: Analysis of extractable and leachable metals in plastic materials of construction as per USP <661.1>
Plastic packaging systems for pharmaceutical use include, but are not limited to bags, bottles, vials, ampoules, cartridges, dry powder and metered dose inhalers, syringes, blisters, pouches and their associated closures and secondary components like labels and printing overpouches…
Plastic materials that are commonly used in packaging systems include polyethylene, polypropylene, cyclic olefins, polyethylene terephthalate, polyethylene terephthalate G, and plasticized polyvinyl chloride, among others.
Drug products can chemically interact with their associated packaging systems and/ or the system’s plastic materials and components of construction while the product is being manufactured, shipped, stored and administered.
As per USP <661.1> the magnitude of these interactions must not be such that the interactions adversely affect the suitability for use of the drug product or the packaging system.
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