Whitepaper: Nitrosamines: analysis for extractables and leachables
This selective detection method greatly improves the prospect of detecting nitrosamines in pharmaceutical products and medical devices that incorporate rubber or latex…
Nitrosamines are potentially carcinogenic and mutagenic compounds  that have been shown to occur in many products, including the rubber seals and stoppers used on process lines, and in some medical devices. As such, there is a risk of nitrosamines appearing in pharmaceutical (and other) products through leaching, and this possibility must be properly evaluated and mitigated by manufacturers prior to marketisation of any product.
The methods traditionally used for the analysis of nitrosamines have been characterised by high cost and complexity. However, the Chemiluminescence detector makes it much easier to develop methods for routine analysis and, also, improves the selectivity and sensitivity of the test.
This selective detection method greatly improves the prospect of detecting nitrosamines in pharmaceutical products and medical devices that incorporate rubber or latex.
This whitepaper is restricted - login or subscribe free to access
Thank you for visiting our website. To access this content in full you'll need to login. It's completely free to subscribe, and in less than a minute you can continue reading. If you've already subscribed, great - just login.
Why subscribe? Join our growing community of thousands of industry professionals and gain access to:
- bi-monthly issues in print and/or digital format
- case studies, whitepapers, webinars and industry-leading content
- breaking news and features
- our extensive online archive of thousands of articles and years of past issues
- ...And it's all free!