Good Identification Practices for Organic Extractables and Leachables Via Mass Spectrometry

The function of a pharmaceutical drug product or a medical device is to provide the patient with a desired therapeutic benefit. If the drug product or the medical device were pure (meaning without impurities), ideally the therapeutic benefit would be largely realized with minimal adverse patient effects. However, since the practical reality is that drug products and medical devices contain impurities, a patient is exposed to these impurities during treatment and these impurities could potentially trigger an increase of adverse patient effects.