Extractables & Leachables

Pharmaceutical laboratories must evaluate the interactions between packaging material and formulation, applying risk assessments defined on ICH Q9 guidelines to guarantee the safety and quality of finished dosage forms being released to the market.

Studies about extractables and leachables are critical for maintaining the quality of your drug product during drug development and final batch release in accordance with GMP compliance. The testing process assesses whether the drug products could be exposed to any harmful leachable contaminants that could have a detrimental impact upon the safety and efficacy of the drug.

In general, extractables and leachables can be divided into three broad groups:

• • Non-volatile leachables
  • Volatile and semi volatile leachables
  • Inorganic/elemental leachables

Elemental Impurities in extractables and leachables are best determined by ICP-OES, ICP-MS, and GC-MS for volatiles whereas HPLC or UHPLC are preferable method for non-volatile compounds. We provide the tools you need to take control of your extractables and leachables testing.