Table 6.

Chemical characteristics categories and associated tests, summarized from [62].

Category	Examples
Traditional Extractable Material Characterization	USP (United States Pharmacopeia) Physicochemical Test Panel for Elastomeric Closures for Injections USP Polyethylene Containers Tests–Heavy Metals and Nonvolatile Residues Indirect Food Additives and Polymers Extractables (21CFR Part 177 Sterilant Residues–Ethylene Oxide, Ethylene Chlorohydrin, Ethylene Glycol
Tests Procedures for Extractable Material	Liquid Chromatography Infrared Spectroscopy (IR) Mass Spectrometry Residual Solvents Atomic Absorption Spectroscopy (AAS) Inductively coupled Plasma Spectroscopy (ICP)
Bulk Material Characterization	Atomic Absorption Spectroscopy (AAS) Inductively coupled Plasma Spectroscopy (ICP) Thermal Analysis Infrared Spectroscopy Analysis to identify and estimate the Gross Composition (For example, Reflectance Spectroscopy, Transmission Spectroscopy
Surface Characterization	IR Reflectance Spectroscopy Scanning Electron Microscopy (SEM)