Extractables and Leachables Testing Service by Drug Development Solutions

With an array of modern technologies, knowledge of regulatory issues, and complimentary CMC analytical capabilities, this makes us your ideal partner for extractables and leachables studies. DDS has a wealth of experience in assessing extractables and leachables for a wide range of products, including: 

Pharmaceuticals 

• Container closure systems (plastic/glass bottles, stoppers, blow seal vials, labels etc.) 
• Pre-filled syringes 
• Transfer systems (tubing, iv bags, connectors etc.) 
• Parenteral, ophthalmic, dermal, topical, orally inhaled and nasal drug products, metered dose inhalers 

Biopharmaceuticals 

• Container closure systems (plastic/glass bottles, stoppers, blow seal vials, labels etc.) 
• Pre-filled syringes 
• Transfer systems (tubing, iv bags, connectors etc.) 
• Single use systems / process contact materials (tubing, gaskets, filters, bags, o-rings etc.)
• Parenteral, ophthalmic, dermal, topical, orally inhaled and nasal drug products, metered dose inhalers 

Consumer healthcare 

• Container closure systems (plastic/glass bottles, stoppers, laminated tubing, labels etc.) 
• Creams, ointments, toothpaste, shampoo 

Medical Devices 

• Whole or component parts according to ISO-10993 (biocompatibility) 

Animal healthcare 

• Container closure systems (plastic/glass bottles, stoppers, blow seal vials, labels etc.) 
• Tags, implants   

Techniques 

• Solvent extraction including ultrasonication, microwave, ASE (Automated Solvent Extraction), Soxhlet and Soxtect 
• Headspace GC-MS (Volatile Organic Compounds) 
• GC-MS and GC-FID (Semi-Volatile Organic Compounds) 
• HPLCDAD- MS/MS (Non-Volatile Organic Compounds) 
• ICP-MS (Inorganic Compounds) 
• Gel Permeation Chromatography (GPC) 
• FT-IR, GC-ToF-MS, HRAM-MS and NMR (structural elucidation and unknown ID) 

Applications 

• Screening studies to aid single use manufacturing component, container closure system component, transfer system component or medical device component selection 
• E&L studies for regulatory submission 
• Managing forced or elective changes in single use manufacturing components, container closure system components, transfer system components or medical device components 
• Method development, validation and technology transfer of analytical methods for product testing and quality control 

Toxicological risk assessment 

The data generated by DDS's E&L studies can be used for toxicological assessment of any specific compounds as part of a human health risk assessment package.  DDS partners with one of Europe’s leading chemical hazard and toxicology risk consultants to provide this service to DSS customers.