Extractables and Leachables

Extractables and leachables are chemicals that can be released/migrated from primary and secondary packing materials such as containers, container liners, closures, closure liners, stopper over-seals, container inner seals, administration ports, overwraps, container labels, administration accessories and shipping containers.

Typical contaminants include pthallate esters, cyanides, nitrosamines, benzopyrenes, trace metals etc.

VIMTA has expertise to determine the potential contaminants in various drug products with the help of following:

• HPLC
• GC
• GC/MS, GC/MS-MS, GC-MS/TOF, HRGC-MS
• LC/MS
• LC/MS-MS
• FTIR
• AAS, ICP-MS