The Impurities Workshop - Part I: General Strategies
Im Auftrag der ECA Academy

The Impurities Workshop - Part I:  General Strategies Im Auftrag der ECA Academy

Copenhagen, Denmark

Seminar Nr. 16404


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Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail:


Speaker from Authority
DR ULRICH ROSE, Strasbourg, France

Industry Speakers
DR CHRISTOPHER DAY, AstraZeneca, United Kingdom
DR MANFRED FISCHER, Skyepharma (member of Vectura group), Muttenz, Switzerland
DR CRINA HEGHES, Lhasa Limited, United Kingdom
DR GERD JILGE, Boehringer Ingelheim Pharma GmbH & Co. KG, Germany
GRACE KOCKS, Lhasa Limited, United Kingdom
DR ANDREW TEASDALE, AstraZeneca, United Kingdom
DR LISE VANDERKELEN, Nelson Labs, Belgium


Part I of the Impurities Workshop will provide an opportunity to reinforce and expand your knowledge of the general area of impurities in chemical entities from initial development to the market with emphasis on

  • Detection, profiling and control of impurities in drug substances, intermediates and drug products
  • Practical aspects of method validation for impurities determination
  • Analytical techniques used for detecting and qualifying impurities
  • Extractables and Leachables as a source of impurities
  • Impurities qualification – examination of approaches based on duration

This event is designed to provide a comprehensive review of impurities analysis and characterisation in drug substances and drug products and their recording and reporting.


Setting specifications for impurities are one of the most critical topics in the development of new drug products. Impurities analysis in drug substances and drug products and their recording and reporting is quite often a challenge for the scientific experts in routine production and quality control. This challenge is even bigger when profiles of unknown impurities in complex matrices have to be established.


This workshop addresses all personnel involved in development of drug substances and drug products from scientific staff to laboratory heads involved in R&D. The needs of Laboratory Managers, Supervisors and Analysts in pharmaceutical quality assurance and quality control departments will also be covered. This event will also address regulatory requirements and hence is applicable to people working in the regulatory affairs area.


Part I: General Strategies

Impurities analysis and qualification of Impurities in Drug Substances and Drug Products – general overview

  • Impurity profiling in synthetic drug substances
  • Qualification of impurities
  • Degradation studies
  • Identification of chiral impurities, polymorphic phases and new impurities
  • Residual solvents
  • Impurities in starting materials and intermediates
  • Pharmacopoeial tests and acceptance criteria
  • Drug product specifications and parametric release
  • Inorganic impurities
Practical aspects of method validation for impurity determination
  • Important ICH and FDA guidelines
  • Quantitation of impurities
  • How to define an impurity profile (stress tests)
  • Reference substances
  • Validation of methods at various development stages
  • Statistical approaches to method validation (LOD & LOQ)
Presentation and Workshop: Analytical techniques for determination and qualification of impurities in Starting Materials and Intermediates
  • Purity analysis by HPLC, impurity profile
  • Residual solvents by GC
  • Inorganic impurities (heavy metals, sulphated ash)
  • For chiral compounds in addition: enantiomeric purity and proof of the absolute configuration
In the Workshop, the participants will learn which activities are necessary to characterise drug substances taking into account the following aspects:
  • Analytical procedures are necessary for the characterisation
  • Experiments necessary to check the downstream impurities in order to justify acceptance criteria for the respective impurities
  • Other impurities have to be taken into account
  • Experiments to be performed in order to get a stability-indicating analytical procedure
Presentation and Workshop: Leachables and Extractables
  • Why should Extractables & Leachables be assessed?
  • Regulatory requirements in the EU and US
  • Compendial requirements and industry standards
  • Safety qualification of Leachables and Extractables

The Workshop will provide the opportunity to work on case studies about Leachables and Extractables regarding detection and safety qualification. It will seek, through a practical exercise, to examine the steps involved in a comprehensive E&L evaluation.


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