The role of ELSIE in evolving current thinking on extractables and leachables

References for ‘The role of ELSIE in evolving current thinking on extractables and leachables’, in European Pharmaceutical Review issue 1 2020.


  1. ICH Assembly, Singapore. November 2019. Available at: [Accessed 27 December 2019].
  2. Nagao et al. The ELSIE Extractable and Leachable Database [Internet]. Pharm. Outsourcing. 01 November 2011. Available at: [Accessed on 27 Dec 2019].
  3. Teasdale et al. Controlled Extraction Studies Applied to Polyvinyl Chloride and Polyethylene Materials: Conclusions from the ELSIE Controlled Extraction Pilot Study. AAPS PharmSciTech. 16(3), 2015, 664-674.
  4. Stults et al. Evaluation of extractables in processed and unprocessed polymer materials used for pharmaceutical applications. AAPS PharmSciTech. 16)1), 2015, 150-164.
  5. ICH Q3D, 2014. Guideline for elemental impurities – Step 4. 16 December 2014.
  6. Jenke et al. Materials in Manufacturing and Packaging Systems as Sources of Elemental Impurities in Packaged Drug Products: A Literature Review. PDA Pharm. Sci. Technol. 69(1), 2015, 1-48.
  7. Broschard et al. Assessing safety of extractables from materials and leachables in pharmaceuticals and biologics – Current challenges and approaches. Toxicol. Pharmacol., 81, 2016, 201-211.
  8. Norwood et al. Best practices for extractables and leachables in orally inhaled and nasal drug products: An overview of the PQRI recommendations. Res., 25(4), 2007, 727-739.
  9. ICH M7. Guideline on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk – Step 4. 23 June 2014.
  10. Extractables and leachables– safety-based limits. EPR, 22(4), 2017, 7.
  11. Joint Pharmaceutical Analysis Group symposium entitled ICH Q3E (Extractables and Leachables): setting the scene. Thursday 7 May 2020. Available at:
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