Nitrosamines – Analysis for Extractables and Leachables

This whitepaper discusses the formation and detection of nitrosamines. It also covers nitrochemiluminescence detectors.

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.

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