Blog:
Navigate the nitrosamine mitigation process, available strategies, and supporting solutions with lead scientist, Elizabeth Tocce.
Tackling nitrosamine risk in pharmaceuticals
Regulatory agencies around the world aren’t taking any chances when it comes to the risk of nitrosamines in pharmaceuticals. To ensure patient safety, regulatory authorities require drug companies to provide risk assessments and, if necessary, mitigation plans for their medicines. While there are many ways to approach nitrosamine mitigation, low nitrite excipients are an effective tool.
Low nitrite excipients block a common route of nitrosamine formation—the reaction between a vulnerable amine in an active pharmaceutical ingredient (API) and nitrite, which can be present at trace levels in excipients. Whether you are looking to develop a new drug or reformulate an existing product, low nitrite excipients may offer a simple solution that can form part of a holistic mitigation strategy.
Discover the benefits of our low nitrite excipient solutions
Backed by decades of innovation, expertise, and a long history of manufacturing high quality pharmaceutical grade excipients, we have created low nitrite grades of our proven Avicel® PH microcrystalline cellulose (MCC) and METHOCEL™ hydroxypropyl methylcellulose (HPMC) excipients.
Through enhanced process controls and industry leading analytical science, we ensure that every batch of our low nitrite Avicel® PH and METHOCEL™ polymers contains less than or equal to 200 parts-per billion (ppb) nitrites. Importantly, our low nitrite grades deliver the same performance and reliability that customers expect from Avicel® and METHOCEL™.
Key benefits include:
- Reduced nitrosamine formation risk
- No impact on API performance or drug product efficacy
- Minimal need for costly or time-consuming reformulation
- Lower regulatory hurdles compared to alternative mitigation strategies
- Seamless integration into existing formulations
Partner with IFF Pharma Solutions
When you collaborate with IFF Pharma Solutions, you're just three steps away from your next successful low nitrite product:
- Discuss your specific low nitrite development and processing objectives with our team
- Receive tailored advice, formulation support and technical guidance
- Get support for your supply and logistical needs to bring your low nitrite solution to life
Resources to support your nitrosamine mitigation strategy
Here you will find a collection of expert content including blogs, webinars, and announcements exploring nitrosamine risk mitigation and the role of low nitrite excipients.
Read now
Webinar:
Uncover a collaborative approach to nitrosamine risk reduction between industry and excipient providers.
Factsheet:
Discover the benefits of Low Nitrite METHOCEL™ for mitigating nitrosamine risk in pharmaceuticals.
Brochure:
See why Avicel® PH Low Nitrite is an indispensable tool for mitigating nitrosamine contamination risk.
Announcement:
Uncover our latest innovation: IFF Pharma Solutions launches Low Nitrite METHOCEL™ for nitrosamine mitigation.
Expert article:
Understand how low nitrite excipients can effectively minimize nitrosamine risk without compromising on efficacy.
Expert article:
Explore five questions you should ask when choosing low nitrite excipients.
