Routine and specialized services to determine and characterize extractables and leachables for a wide range of materials and products.
E/L Services (Manchester, UK)
Design of study protocols and experimental programs
Controlled Extraction Studies (CES) performed using different polarity solvents to provide a comprehensive extractables profile
Development of analytical methods including LC-MS, GC-MS and ICP-OES for the identification and quantification of organic and inorganic components generated during the CES
Identification of ‘special case’ compounds in OINDP’s such as polyaromatic hydrocarbons (PAHs), N-nitosamines and 2-mercaptobenzothiazole
Adaptation and development of CES analytical methods for use in leaching studies to assess the degree of drug substance or drug product contamination
Application of leachables analysis during long term drug substance or drug product storage stability trials
Routine extractables testing for quality control purposes
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