TABLE VI

Comparison of Compendial Testing versus Extractables Testing

Property of the Methodology	Present in the Methodology
Property of the Methodology	Compendial Testing	Extractables1 Profiling
1. Involves an extraction	Yes	Yes
a. Uses a solvent with similar extracting propensity as the drug product.¹	No	Yes
b. Uses extraction conditions that simulate (accelerate) actual contact.²	No	Yes
2. Involves testing of an extract	Yes	Yes
a. Produces an identity of the individual extracted substances.	No	Yes
b. Produces concentration estimates for the individual extracted substances.	No	Yes
3. Produces information that can be safety assessed.	No	Yes

↵1 The term drug product is used here to reflect any solution that may be contacted by a plastic material during the manufacture, storage, or delivery of a drug product.
↵2 This contact is between a solution and a plastic used in manufacturing or packaging.