Leachables/Extractables/Particulates

Container closure systems, drug delivery devices, and packaging materials can introduce potentially harmful chemical entities into drug products — making Extractables and Leachables (E&L) testing a critical component of pharmaceutical safety and regulatory compliance. ResolveMass Laboratories offers ad...

We offer the development and validation of test methods for identity testing, assay, purity testing and in vitro dissolution for active ingredients, excipients, intermediates, finished products and substance-based medical devices. Our method development and method validation are in accordance wit...

LabAnalysis is a family owned CRO offering innovative and reliable solutions to Quality Controls andResearch and Development Departments. Customer Care and Commitment to Quality are the driving forcesfor our continuous and sustainable growth with a proven track record of long last business partnershipsarou...

Your Trusted Partner in Ensuring Regulatory Compliance
Since 2008, mdi has been a trusted partner to the pharmaceutical and biopharma industries, providing asertain® validation services that support the regulatory approval of drug products. Our extensive experience spans a wide range of formul...

Früh Cleanfilm® - High Barrier Laminates deliver superior protection for pharmaceutical and biopharmaceutical applications. With outstanding gas barrier properties, minimized water vapor and CO₂ loss, and high transparency, they ensure maximum product stability. Aluminium- and PVC-free, our lamin...

Fundamental to your biopharmaceutical chemistry, manufacturing and controls (CMC) development, you will need detailed analytical characterisation data to satisfy regulatory requirements. Our experts strategically deploy orthogonal protein analysis approaches that address key molecular and biological charac...

Through Recipharm Analytical Solutions™, we support customers with stand-alone analytical requirements. Our analytical development team has experience from developing hundreds of analytical methods every year, supporting development of formulations ranging from powder in capsules and IV solutions to ER tab...

There are many contaminants that could be released inside a drug during the production process or by contact with the packaging material. Neotron Pharma will be able to support you from the study of Extractables, to the toxicological evaluation up to the control of the Leachables. What distinguishes us is ...

Extractables & leachables studies enable drug sponsors to quantify and identify the risks of potentially toxic leachable impurities migrating into a drug solution from container closure systems, processing equipment or packaging. Regulatory bodies such as the US Food and Drug Administration (FDA) and T...

Development of nasal drugs: Scientists from our nasal drug development team provide method development, validation, and testing services to help you optimise the performance of your aqueous, powder, and propellant-driven nasal drug products. Conducted in Good Manufacturing Compliant (GMP) laborato...

Impurities and contaminants analysis in biotechnology products from SGS – a range of services providing impurities and contaminants characterization in biotechnology derived products and microbial contamination control.To help you meet ICH Q6B guidelines, you need accurate impurities and contaminants analy...

Delivering a product from discovery to the market is a long and often difficult process filled with a great number of scientific, safety and regulatory challenges. From early discovery to final product release, SGS offers a broad portfolio of high quality, analytical chemistry services using advanced metho...

 SGS realizes that the package or container that carries your product is vital to its safety and efficacy: a weak container, or one that allows contamination of your product, could put the health of your customers and your reputation at risk. SGS package and container testing services offer a ran...

Element’s pharmaceutical laboratories provide specialist pharmaceutical testing services, including chemical and physical characterization, formulation development, microbial, stability and elemental impurity testing on a wide range of products, from raw materials to finished products.

Element's E&L teams use industry-leading expertise, in-depth knowledge of materials and regulatory requirements to help customers assess the potential for leachables, develop strategies to evaluate risk and provide a solid risk-based set of supporting data.

Extractables/Leachables (E&L) profiles have as a primary purpose identifying any potential chemicals derived from the chemical interactions of a drug with the packaging components ,or the interaction within the pharmaceutical drug formulation.
In addition, E&L is a FDA, ICH, and USP studies...