Leachables/Extractables/Particulates

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...

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 ...

Alcami’s expertise includes the assessment of a broad variety of drug products, routes of administration, and manufacturing system components. A proper assessment includes studies to not only understand which compounds have the ability to leach into the drug product, but also studies to identify which comp...

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...

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...

 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...

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...

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...

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...