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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

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.

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

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.

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 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.

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.

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.

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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