Sources of Leachables

June 30, 2018

Leachables are compounds that migrate into a drug product from the sample container closure system (CCS) under normal storage condition.  Leachables can enter any type of drug product including solid dosage forms.  Generally, orally inhaled and nasal drug products (OINDP) and parenteral and ophthalmic drug products (PODP) are the most common drug products at high risk of leachables.

Both the primary CCS in direct contact with the drug product (metered dose inhaler, prefilled syringe, eye dropper, IV bag, HDPE bottle, LDPE ampoule, etc.) and the secondary CCS which does not contact the drug product (printed label, cardboard box, foil pouch, environmental exposure, etc.) can be sources of leachables. Leachables present a potential risk to the patient both from the toxicity of the leachable and from the possible negative impact upon stability and efficacy of the drug product.  Examples of common leachables can be seen in the table below.