Table 3.

Assessment of drug product leachables associated with pharmaceutical packaging/delivery systems (modified from “FDA/CDER/CBER risk-based approach to consideration of leachables” (USP—General chapter <1664>) [148]).

Degree of Concern Associated with the Route of Administration	Likelihood of Packaging Component–Dosage Form Interaction
	High	Medium	Low
Highest	Inhalation aerosol and spray	Injections and injectable suspensions, inhalation solution	Sterile powders and powders for injection, inhalation powders
High	Transdermal ointment and patches	Ophthalmic solutions and suspension, nasal aerosol and spray
Low	Topic solutions and suspensions, topical and lingual aerosol, oral solutions and suspensions		Oral tablets and oral (hard and soft gelatin) capsules, topical powders, oral powders