HORIBA's highly accurate trace gas analyzers can continuously monitor N compounds (NO, NO2, N2O etc.) to help clarify the cause of nitrosamine formation during the formulation granulation process.
Recently, nitrosamines, which are likely carcinogenic to humans, have been detected globally in the Sartan class of drugs, Ranitidine and Nizatidine. Medicines regulatory authorities, including the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), and the Japanese Ministry of Health and Welfare (MHLW), have issued notices and guidance to pharmaceutical manufacturers and distributors, requesting self-inspection and assessment regarding the risk of nitrosamine contamination. The mechanism of nitrosamine formation is still under research, but one hypothesis suggests atmospheric N compounds could cause nitrosamine formation when ambient air is heated and used for drying formulation during the granulation process.
Advantages of APNA-380
*Standard specification is LAN connection. For wireless connection, separate device is required. *Modbus is a trademark of Schneider Electric USA Inc.
Nitrogen Oxides Monitor APNA-380
Laser Scattering Particle Size Distribution Analyzer
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