Impurities Forum- Part I: General Strategies

Impurities Forum- Part I:  General Strategies

Copenhagen, Denmark

Course No 15861


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Speakers from Authority & United States Pharmacopeia
Dr Ulrich Rose, EDQM, France
Dr Kahkashan Zaidi, USP, USA

Industry Speakers
Dr Gerd Jilge, Boehringer Ingelheim Pharma, Germany
Dr Samuel Powell, Pfizer, UK
Dr Xaver Schratt, LPU GmbH, Germany
Dr Andrew Teasdale, AstraZeneca, UK
Dr Lise Vanderkelen, Toxicon Europe, Belgium


Part I of The Impurities Forum 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
  • Stress stability testing as a tool to determine degradation pathways
During this event you will get to know the relevant aspects of impurities analysis, characterisation and control 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.

Target Group

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


Impurities analysis and qualification 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
Control of organic impurities in the European Pharmacopoeia
  • Ph. Eur. analytical techniques used for impurity control
  • Impurity control in general chapters and monographs: General monograph 2034, General chapter 5.10 - control of impurities, General chapter 2.2.46 - chromatographic separation techniques
  • Qualitative and quantitative control: System suitability tests, Methods of quantification, Limit test vs quantitative test
  • Response and correction factors
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 puritymand 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
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
Stress stability testing during development
  • Elucidation of impurities of the drug substance
  • Identification of possible degradation products
  • Check of the degradation pathways
  • Typical experiments
  • Test parameter
  • Storage conditions
  • Stress tests of multi-use products
  • Impact on excipients and packaging materials

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