Nitrosamine Risk Reduction in Pharmaceutical Formulations: A Collaborative Approach Between Industry and Excipient Providers

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Webinar Date/Time: Wed, Nov 1, 2023 11:00 AM EDT

In this webinar, you will learn from industry experts about collaborative strategy that helps mitigate the nitrosamine risk in your drug formulations. Experts will address the industry’s core need for reliability, sustainability, quality, and predictable performance standards in drugs to develop and produce robust formulations.

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Event Overview:

Nitrosamine risk assessment and control have become an integral part of pharmaceutical drug development and the quality evaluation process. Regulatory bodies mandate that manufacturers of active pharmaceutical ingredients and finished pharmaceutical products must evaluate the risk of nitrosamines and take appropriate risk-mitigating measures.

During this webinar, industry experts will share strategies to mitigate the nitrosamine risk. This webinar will capture the key risks and root causes of nitrosamine formation in drug products. Speakers will use model amine studies to confirm risk factors and predictive models in support of risk assessments. This webinar will also cover excipient supplier strategies for managing nitrite impurities and analytical methods to quantify nitrite content in a consistent and reliable manner.

Key Learning Objectives:

  • Causes and risks of nitrosamine formation in pharmaceutical dosage drugs
  • Risk mitigation strategies considered by the pharmaceutical industry and the excipient manufacturer
  • Use of model amine studies to confirm risk factors and inform the magnitude and extent of nitrosamine formation
  • Development and use of predictive models for nitrosamine formation in support of risk assessments
  • Analytical method development and support to monitor nitrite in excipients
  • Case studies with respect to low nitrite excipient offering

Who Should Attend:

  • Formulation scientists
  • Process scientists
  • Pharmaceutical manufacturers
  • Quality and analytical scientists
  • Regulatory managers


Justin Moser
Principal Scientist – Vaccine Drug Product Development
Merck & Co.

Justin Moser is a Principal Scientist at Merck & Co., Inc. within the research and development division. His role is in vaccine drug product development focusing on formulation and process design, clinical supply support and scale-up and technology transfer to the manufacturing division. Prior to this assignment and at the beginning of 2020, Justin led the drug product N-nitrosamine risk evaluation team chartered with building data and understanding that can be utilized to assess risk for Merck & Co., Inc. marketed products. He took over leadership of the overall cross-functional N-nitrosamines core risk team which authored and submitted the risk assessment outcomes to health authorities.

He has a B.S in Chemical Engineering from The Pennsylvania State University and has been working at Merck for over 21 years. Justin’s experience in drug product development spans candidate approval through commercial process validation and product registration. He has held roles of increasing responsibility from bench level scientist through team leader of cross-functional teams developing oral solid dosage drug products from drug candidate approval into phase 3 and registration stability lot execution. He has also led technology implementation of spray drying at Merck for over 13 years including managing outsourced development and manufacture, design and installation of a pilot scale spray drying plant and authoring several core sections of the dossier for Merck’s first spray dried amorphous dispersion product Zepatier. He is an author on over 17 publications, co-inventor on 8 patents and presented at numerous conferences. Most recently, he served as an author of the editorial for the J. Pharmaceutical Sciences special edition on N-nitrosamines and lead author on an included publication addressing N-nitrosamine formation risk in solid drug products.

Dr. Meinolf Brackhagen
IFF’s Pharma Solutions

Dr. Meinolf Brackhagen is a Principal Pharma Application Scientist at IFF's Pharma Solutions. His responsibilities include technical service and development for the Pharma application markets as well as in-depth analysis of structure/property relationships used to commercialize new products and assist customer´s developments.

Prior to his current role at IFF, Meinolf spent 20 years in different assignments with increasing leadership responsibility at Bayer, Dow and DuPont R&D, and more than 10 years in Pharma Solutions working with excipients and applications.

Dr. Meinolf Brackhagen holds a diploma in Organic Chemistry from the Technical University of Dortmund (Germany) and a PhD in Carbohydrate Chemistry from the University of Rostock (Germany). He is a certified Six Sigma Black Belt. Dr. Meinolf Brackhagen is the author or co-author of more than 40 published patent applications and eight articles in peer-reviewed journals.

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