Leachables/Extractables/Particulates

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 tablet...

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) laboratorie...

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 the...

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 The ...

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.

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.

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 he...