Contact

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.

Contact

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.

Contact

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.

Contact

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.

Contact

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.

Contact

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.

Contact

Leachables & Extractables Studies

Analytical >> Extractables and Leachables >> Testing Services

Analytical research and development (AR&D) offers standalone services and supports our formulation development activities.

Contact

Physical & Physio-Chemical Determinations

Analytical >> Extractables and Leachables >> Chemical Characterization

Physical and physio-chemical determinations (e.g. pH,nconductivity, viscosity, melting point, refractometer, polarimeter, sub-visible particle counter, osmolality, loss on drying)

Contact

Characterization of Extractables & Leachables

Analytical >> Extractables and Leachables >> Testing Services

Aptar Pharma Can Assist You To Select And Test Primary Packaging Components, Containers And Systems As Well As Drug Delivery Devices.

Contact

Genotoxic Evaluation

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

Genotoxicity of the impurity can be evaluated based on FDA approved software. It offers genotoxic and Potential extractable and leachables studies and stablishment of Specification and acceptance criteria

PharmaCompass >>