Extractables & Leachables Services

GMP Services Supporting Product Identity Confirmation, Purity & Quality

Pharmaceutical Expertise for GMP & CMC Testing

Intertek’s Pharmaceutical Services laboratory in Whitehouse, NJ is an FDA and DEA registered cGMP compliant facility, specializing in complex and routine testing services to support the development of drug products, formulations, medical devices and drug delivery systems. We have pharmaceutical expertise for various GMP and CMC testing, including method development and validation, stability, extractables and leachables, and elemental impurities.

Glass delamination testing is necessary to evaluate the inner surface durability of glass containers and their interactions with drug products.

Detection and quantification of nitrosamine impurities, found in some ARB medicines, according to the FDA headspace gas chromatography-mass spectrometry (GC/MS-HS) method.