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Nitrosamine risk remains a critical and complex challenge in pharmaceutical development and manufacturing. Despite the continued evolution of regulatory guidance, there is still a need for greater alignment on analytical approaches, deeper understanding of nitrosating agents involved in nitrosamine formation and effective mitigation strategies.
This joint webinar combines the external analytical perspective of Dr. Andrew Teasdale with the excipient expertise of Ashland solvers Kapish Karan, MS and Dr. Fan Wu to provide a practical view of nitrosamine risk and mitigation strategies. The session will explore nitrosating agents beyond nitrites, mitigation strategies - highlighting how low nitrite excipients can support a robust, risk-based control approach - and analytical challenges.
This hourlong session will highlight practical insights into:
Register for the webinar replay today to gain understandings of nitrosating agents, integrated mitigation strategies and analytical challenges.
presenter information:
Kapish Karan, MS
Senior Global OSD Leader, Pharma R&D
Ashland
At Ashland, Kapish focuses on pharmaceutical oral solid dosage, leading long-term innovation and providing support for strategic customers. He has over fifteen years of experience in oral solid dosage formulation and manufacturing, including the unit operations involved in oral dosage form preparation, as well as the design of immediate and modified-release coating products. His recent expertise has expanded into continuous processing as it relates to the manufacturing of oral solid dosage forms.
He holds several patents pertaining to pharmaceutical and nutritional supplements dosage form design and film coating technologies and has published and presented on granulation, coating technology, and taste masking at various technical conferences. 
Andrew Teasdale, PhD
Director
AT CMC Solutions Limited
Dr. Andrew Teasdale has more than 30 years’ experience in the pharmaceutical industry as an analytical chemist and within quality assurance and regulatory roles. Recently retired from AstraZeneca, Andrew previously chaired AZ’ Impurity Advisory Group. He has also led several industry organizations, including being a past chair of the Extractables and Leachables Safety Information Exchange (ELSIE) and the Joint Pharmaceutical Analysis Group (JPAG), as well as a member of the Royal Pharmaceutical Society (RSC) science board. He has also led several industry expert groups, including both safety and quality groups within Pharmaceutical Research and Manufacturers of America (PhRMA), European Federation of Pharmaceutical Industries and Associations (EFPIA), Product Quality Research Institute (PQRI). He has also represented EFPIA in ICH Q3C-D-E working groups.
Andrew has published a number of books and papers relating to ICH Q’ guidelines, mutagenic impurities, N-Nitrosamines, extractables and leachables, and other impurity related matters.
Fan Wu, PhD
Technical Director of Global Measurement Science
Ashland
Dr. Fan Wu is responsible for enabling the creation of innovative and sustainable Ashland platform technologies, through comprehensive analytical characterizations and fundamental understanding of structure/property relationship.
Dr. Wu is the vice-chair of the excipient expert committee, chair of the joint subcommittee on excipient composition, and member of the povidone/crospovidone expert panel at the United States Pharmacopeia (USP) since 2010. He received a Ph.D. in organometallic chemistry from the University of Chicago, followed by a postdoctoral fellowship at Brookhaven National Laboratory.
Looking to learn more about Ashland low nitrite excipients? Please reach out to your local Ashland solver about our grades:
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