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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, which articulate the framework for the medical device industry to meet safety testing needs through the use of analytical chemistry & biological/toxicological assessment.

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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, including single use systems (SUS), final container/closure, drug delivery devices and overall packaging configuration of your product.

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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.

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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.

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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.

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Assessment of Leachables & Extractables In Drug Products

Analytical >> Extractables and Leachables >> Testing Services

Primera specializes in customized analytical method development, transfer and validation using state-of-the-art analytical tools. We also provide cGMP Sample Storage and testing services. With no observations and no 483 findings from two FDA audits, We are in full compliance with GLP/cGMP regulations.

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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.

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Assessment of Leachables & Extractables In Drug Products

Analytical >> Extractables and Leachables >> Testing Services

Our scientists conduct extractables and leachables studies in accordance with Good Manufacturing Practices (GMPs) ,PQRI recommendations, United States Pharmacopeia (USP) requirements.

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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.

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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.

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