Reliable detection and quantification of nitrosamines and mutagenic impurities.
Due to the presence of unacceptable levels of mutagenic nitrosamine impurities, several pharmaceuticals have recently been recalled. To accurately detect and quantify trace amounts of mutagenic impurities in pharmaceuticals, Agilent offers relevant GC/MS, LC/MS, and high-throughput MS-based analytical techniques.
<Challenges in Nitrosamine Analysis>
1. Introducing mass spectrometers requires meeting regulatory requirements, which can be cumbersome.
2. There are many target substances, making it difficult to choose which method/device to use for GC/MS or LC/MS.
3. Due to the high cost of the equipment, results that justify the expense are expected (in terms of cost, operation, speed from introduction to startup, and decisions on outsourcing).
4. It is challenging to foresee whether the risk assessment can be completed by the deadline.
<Solutions for Nitrosamine Analysis>
Agilent's application guide provides various validated methods from sample preparation to measurement analysis, enabling quick setup and support from introduction to operation. Additionally, regulatory compliance, including data integrity, is achievable.