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.
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★ Application guide now available https://www.chem-agilent.com/contents.php?id=1006706 On October 8, 2021, the PMDA issued measures against the risk of nitrosamine contamination in pharmaceuticals. https://www.pmda.go.jp/safety/info-services/drugs/0371.html ★ Webinar on nitrosamine analysis now available https://www.chem-agilent.com/form_webinar/?name=29_22_LCTUES_ES_JA-06
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Agilent was born out of the Hewlett-Packard Company's spin-off in 1999. Since then, we have received numerous awards related to innovation and have obtained patents for inventions that surpass those accolades. More importantly, the number of customers we serve has been increasing year by year, demonstrating the strength of our partnerships. Agilent has become a leader in the life sciences, diagnostics, and applied chemistry markets. We provide instruments, services, consumables, applications, and expertise to laboratories around the world, contributing to the discovery of insights that our customers are exploring. Through our expertise and reliable collaboration, we offer highly dependable solutions to our customers.