Chemical Characterization

Analytical >> Extractables and Leachables >> Chemical Characterization

AMRI's experts work directly with regulators to participate in standard setting activities for ISO 10993-18 & ISO 10993-17

Extractables & Leachables for Pharma & Biotech

Analytical >> Extractables and Leachables >> Testing Services

AMRI offers a complete suite of extractables and leachables (E&L) testing services to assist in the evaluation of the manufacturing process

Impurities

Analytical >> Extractables and Leachables >> Impurities

AMRI's experts help you determine and quantify the impact of potential genotoxic impurities on drug efficacy through toxicological risk.

Toxicological Risk Assessment (TRA)

Analytical >> Extractables and Leachables >> Toxicological Risk Assessment (TRA)

AMRI offers toxicological risk assessment (TRA) services to evaluate risks to patient health by assessing the leachates of a system against information on in vitro tests, animal studies, computational methods and predictive means.

Extractable & Leachable Testing

Analytical >> Extractables and Leachables >> Testing Services

With a nationwide network of 29 environmental laboratories, 3 life sciences labs, 2 LabOps locations, and 46 service centers, Pace Analytical offers compendia (USP, EP, JP) methods of analytical services for qualitative and quantitative assessment of raw materials, APIs and Finished Products.

Extractables & Leachables Testing

Analytical >> Extractables and Leachables >> Testing Services

Whether you are evaluating container closure systems, delivery devices, single-use systems or manufacturing equipment, Eurofins BioPharma Product Testing offers a broad range of services to support extractables and leachables testing.

Extractables & Leachables analysis

Analytical >> Extractables and Leachables >> Testing Services

Boston Analytical's staff has experience evaluating Extractables & Leachables in pharmaceutical packaging, medical devices, drug-delivery/combination products, processing equipment, Single Use Systems, e-cigarettes, and consumer product packaging.

Extractable & Leachable Studies

Analytical >> Extractables and Leachables >> Testing Services

Our integrated product development services help biopharmaceutical companies shorten time to market, manage risk and access new global markets to maximize portfolio value.

Assessment of Leachables & Extractables In Drug Products

Analytical >> Extractables and Leachables >> Testing Services

Our extractables and leachables analytical services include: Modify and validate controlled extractable methods for testing and profiling of leachables and Develop HPLC, GC, and MS methods for controlled extractables from pharmaceutical containers, closures and devices.

Extractables & Leachables Testing For Delivery Systems

Analytical >> Extractables and Leachables >> Testing Services

West offers extractables/leachables analysis for packaging and delivery systems for all pharmaceutical and biological products.