Extractable Material Characterization

■ USP physicochemical tests: plastics

■ USP physicochemical test panel for elastomeric closures for injections

■ USP polyethylene containers tests: heavy metals and nonvolatile residues

■ Indirect food additives and polymers extractables (21 CFR 177)

■ Sterilant residues: ethylene oxide, ethylene chlorohydrin, ethylene glycol

■ Metals determination by atomic absorption spectroscopy

■ Extractable metals

■ Total metal content

■ Nonroutine characterization of organic extractable material

■ Ultraviolet/visible spectroscopy

■ Gas chromatography

■ Liquid chromatography

■ Gravimetry

■ Protein assay

■ Infrared spectroscopy

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