Elemental Genotoxic Impurities 2~3 November Hyderabad
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Press release : 2nd Annual of CPhI’s ‘Elemental and Genotoxic Impurities’ Conference in Hyderabad

October 12, 2017
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Elemental Genotoxic Impurities 2~3 November Hyderabad
Elemental Genotoxic Impurities 2~3 November Hyderabad

UBM India announces 2nd Annual of CPhI’s ‘Elemental and Genotoxic Impurities’ Conference in Hyderabad 

Hyderabad, 2nd November 2017: CPhI Conferences, a division of UBM India which hosts a number of successful pharmaceutical conferences is pleased to announce the 2nd annual edition of ‘Elemental and Genotoxic Impurities Conference scheduled on 2nd–3rd November 2017 at The COURTYARD BY MARRIOTT, Hyderabad.

In the pharmaceutical world, an impurity is considered as any inorganic, organic material or residual solvent other than the drug substances that arise during synthesis or unwanted chemicals that remain with Active Pharmaceutical Ingredient’s (API’s). In order to increase the safety of drug therapy, impurities should be identified and quantified by selective methods.

USFDA is giving increasing importance on the assurance of quality and safety of a drug by controlling the impurities and monitoring the degradation of products. The major challenge for both bulk drug industries and pharmaceutical industries is to produce quality products. The presence of impurities even in small amounts may influence the efficacy and safety of the pharmaceutical products. Identification or characterization and quantification of the impurities and related substances will help in minimizing or avoiding the risk and obtain a pure substance with less toxicity and safety in drug therapy. Impurity profiling includes identification, structure elucidation and quantitative determination of impurities and degradation products in bulk drug materials and pharmaceutical formulations.


Elemental & genotoxic impurities are very important subject matter in the pharmaceutical industry. Recent guidelines have provided valuable insight into the regulatory requirements with respect to risk assessment, risk characterization and controlling of these types of impurities.

Now a days, not only purity profile but also impurity profile has become mandatory according to various regulatory authorities. Regulatory authorities like ICH, USFDA, Canadian Drug and Health Agency are emphasizing on the purity requirements and the identification of impurities in API’s.

Impurity profiling has gained importance in modern pharmaceutical analysis due to the fact that unidentified, potentially toxic impurities are hazardous to health. The control of pharmaceutical impurities is currently a critical issue to the pharmaceutical industry.  Impurity profiling has been in the limelight in the recent pharmaceutical scenario and its importance is increasing day-by-day.

To tackle with this ongoing industry challenge and bridge the gap between internal audits and external obligations, CPhI India launches the 2nd edition of ‘Elemental and Genotoxic Impurities’ conference.

This conference will focus on the details delineated in these guidelines and elaborate on the challenges that industry is experiencing when attending to these types of impurities in drug substances and drug products

This conference is bifurcated into the workshop model on Day 1 for “Genotoxic Impurities” and Conference Model on Day 2 for “Elemental Impurities”. The workshop will feature Dr. Raphael Nudelman, Director of Chemical & Computational Toxicology at Teva Pharmaceutical Industries Ltd. where he heads the impurity justification and qualification of Teva’s drug substances and drug products. He has been a guest speaker at many of the international conferences on this topic. Dr. Nudelman also served as the President of the Medicinal Chemistry Section of the Israel Chemical Society from 2011 to 2016.

The summit promises to witness large gathering of the industry stalwarts on the rostrum to enhance your knowledge on impurity profiling.

Key topics of the conference include


  • Genotoxic impurity profile overview
  • Evaluation of the ICH M7 guideline and its applications
  • Risk assessment and control strategies for mutagenic impurities
  • Documentation
  • Case studies


  • Elemental impurity profile overview
  • Effect of extractables and leachables on impurities
  • Risk assessment and control of elemental impurities
  • Analytical techniques

About UBM India:

UBM India is India’s leading exhibition organizer that provides the industry with platforms that bring together buyers and sellers from around the world, through a portfolio of exhibitions, content led conferences & seminars. UBM India hosts over 25 large scale exhibitions and 40 conferences across the country every year; thereby enabling trade across multiple industry verticals. A UBM Asia Company, UBM India has offices across Mumbai, New Delhi, Bangalore and Chennai. UBM Asia is owned by UBM plc which is listed on the London Stock Exchange. UBM Asia is the leading exhibition organizer in Asia and the biggest commercial organizer in mainland China, India and Malaysia.

For further details, please visit www.ubmindia.in

About UBM plc:

UBM plc is the largest pure-play B2B Events organiser in the world.  In an increasingly digital world, the value of connecting on a meaningful, human level has never been more important.  At UBM, our deep knowledge and passion for the industry sectors we serve allow us to create valuable experiences where people can succeed. At our events people build relationships, close deals and grow their businesses.  Our 3,750+ people, based in more than 20 countries, serve more than 50 different sectors – from fashion to pharmaceutical ingredients.  These global networks, skilled, passionate people and market-leading events provide exciting opportunities for business people to achieve their ambitions.

For more information, go to www.ubm.com; for UBM corporate news, follow us on Twitter at @UBM, UBM Plc LinkedIn

Media Contact:

Roshni Mitra / Mili Lalwani

roshni.mitra@ubm.com / mili.lalwani@ubm.com


UBM India

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