Pharmacopeia Testing

The packaging used for drug products is fundamental to their integrity and long term stability. Containers may need to protect the drug product from the effects of moisture, oxygen and light whilst substances which may leach from the packaging material must not affect the safety or efficacy of the drug.

The various pharmacopeias include monographs which prescribe how the physicochemical properties of packaging materials and their permeability should be assessed. Smithers Rapra can perform these tests on your packaging materials and containers:

• USP <381> (Elastomeric Closures for Injections)
• USP <661> (Containers – Physicochemical Tests)
• USP <671> (Containers – Permeation)
• Ph Eur 3.1 to 3.1.15 (Materials used for the Manufacture of Containers)
• JP (Test for Rubber Closure)
• JP (Test Methods for Plastic Containers)
• Various other Monographs