Mitigating Nitrosamine Risks: A Closer Look
Explore our publications about Nitrosamine mitigation.
United for safety – why Nitrosamine control matters
- 1Alternative Approaches to Nitrosamine Mitigation
- 2DFE’s nitrosamine mitigation strategies
- 3Nitrosamine mitigation solutions from Roquette Health & Pharma
- 4United for safety - Navigating innovation with nitrosamine risks
- 5Webinar: United for safety - smarter excipients for nitrosamine risk mitigation
- 6Webinar: From lab to label - Analytical method advances in measuring nitrite in pharmaceutical excipients
Why are nitrosamines still on every regulator’s radar and why ignoring them is risky.
About the webinar
Nitrosamines continue to be a concern in pharmaceutical manufacturing due to their potential carcinogenicity and regulatory scrutiny. This webinar explores the origins of nitrosamine impurities, their impact on drug safety, and practical strategies for risk mitigation through excipient selection and process optimisation. Attendees will gain insights into regulatory guidelines, analytical approaches, and innovative solutions to ensure compliance and patient safety.
Nitrosamine impurities have led to global recalls, product withdrawal, and heightened regulatory oversight, making risk mitigation a high priority for pharmaceutical companies during product development and risk assessment.
Webinar details
Language: English
Duration: 45 minutes + Q&A
Format: Available on demand
Key learnings
- Understand the Risk: Nitrosamines are probable carcinogens; even trace levels can trigger recalls and product withdrawal.
- Know the Sources: Nitrosamines can form from nitrites in excipients, manufacturing conditions, and raw materials.
- Regulatory Compliance: Familiarise yourself with acceptable exposure limits and global regulatory expectations.
- Mitigation Strategies:
- Select excipients with minimal nitrite content: low-nitrite excipients offer enhanced safety, stability, and compliance.
- Optimise manufacturing processes (e.g., direct compression vs. wet granulation)
- Implement continuous monitoring and validated analytical methods.
- Market Advantage: Using low-nitrite excipients can reduce risk, improve product quality, and differentiate your drug product.
Join the IMCD Pharma team in this informative webinar to help separate fact from hype and ensure your formulations stay safe, compliant, and competitive.
To learn more about Nitrosamine mitigation, please fill in the form to reach out to our experts!
About the speakers
Dr. Manish Ghimire, Director of Technical Development, IMCD North America
With over 15 years of expertise in pharmaceutical R&D and technical marketing across both the U.S. and European markets, Manish is a dynamic leader dedicated to advancing drug formulation and delivery systems. Specialising in immediate and modified-release solid dosage forms - including tablets, capsules, and multiparticulates, Manish has a strong focus on solutions tailored for pediatric and geriatric patients. In his previous roles, he helped advance DOE and Multivariate Analysis (MVA) for optimal product development.
An accomplished communicator, Manish has authored numerous peer-reviewed publications, presented over 25 scientific posters, and delivered over 100 oral presentations at prestigious global pharmaceutical companies, webinars, and seminars. His ability to translate complex scientific concepts into actionable strategies makes Manish a sought-after speaker and thought leader in the pharmaceutical field.
Dr. Simon Roberts, Controlled Release Manager, IMCD EMEA
After completing a BSc in Chemistry, Simon studied Biopolymer Mixtures for his PhD. This was followed by several academic research positions investigating super absorbent materials, carbon nanotube rheology, dental and medical materials, pulmonary drug delivery and protein-polysaccharide drug conjugates.
After leaving academia he spent five years in a global technical support role in the oral drug products group of a multinational pharmaceutical company, responsible for technology transfers, excipient introductions, process scale up and trouble shooting. Since 2011, he has worked for excipient manufacturers and distribution companies in technical sales and scientific business development roles.
Discover more
IMCD offers science‑driven expertise in the field of nitrosamines, helping customers navigate a complex topic with confidence while maintaining a strong focus on quality and safety. As a trusted supplier of a wide range of APIs and excipients, we provide well‑characterised, reliable materials that support robust formulation and informed decision‑making at every stage of development. In addition to technical guidance, our portfolio includes dedicated products designed to support nitrosamine mitigation, enabling manufacturers to address regulatory expectations and strengthen the safety profile of their formulations.
Explore our dedicated product pages to find solutions that align with your needs and connect with our experts for further insight and guidance.
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Mitigating Nitrosamine Risks: A Closer Look
Explore our publications about Nitrosamine mitigation.
United for safety – why Nitrosamine control matters
- 1Alternative Approaches to Nitrosamine Mitigation
- 2DFE’s nitrosamine mitigation strategies
- 3Nitrosamine mitigation solutions from Roquette Health & Pharma
- 4United for safety - Navigating innovation with nitrosamine risks
- 5Webinar: United for safety - smarter excipients for nitrosamine risk mitigation
- 6Webinar: From lab to label - Analytical method advances in measuring nitrite in pharmaceutical excipients