Extractables and leachables service by LGC

Manufacturer LGC  |  Available Worldwide
Extractables and leachables studies are essential in providing the necessary analytical data for regulatory submission. 


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Extractables and leachables service
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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. LGC have 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 LGC's E&L studies can be used for toxicological assessment of any specific compounds as part of a human health risk assessment package.  LGC partner with one of Europe’s leading chemical hazard and toxicology risk consultants to provide this service to LGC customers.