91AV

Introduction

For nearly three years, the nitrosamine challenge has exponentially expanded and is one of the major issues facing the global pharmaceutical industry. It has resulted in product recalls and as such it has become high profile within the media. From the early focus on trace nitrosamine levels in drug substance, the scope has expanded to drug product, associated excipients, and the risk of nitrosamine formation in packaging processes. As the scope has expanded, the trace analysis challenge has grown. LOQs and LODs were typically set at 15ppb and 5ppb respectively, however, recent regulatory challenge may drive these down further to LOQs in the region of 5ppb and LODs at the 1 ppb level. This presentation will focus on the vast range of activities and the technical challenge of nitrosamine trace analysis. Areas of innovation will be demonstrated in this challenging area of analytical science. Issues of method robustness, sample preparation and a number of unexpected sources of nitrosamine contamination and the risk of false positives with also be described. In addition, the scientific progress made towards an understanding of the root cause of nitrosamine formation will be explored.

Speakers

• Tony Bristow AstraZeneca (Macclesfield), United Kingdom

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Venue

United Kingdom

Committee

• Phil Kay JMP, United Kingdom

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Contact information

Phil Kay
JMP
Contact us by email

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