Nitrosamine Prevention in the Granulation Process of Pharmaceuticals

ー Continuous Monitoring Trace-level Gas Concentration ー 

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.

Do you face any challenges for monitoring impurities in granulation process of pharmaceuticals?

  • Want to identify causative substance (NO, NO2, N2O etc.)
  • Want to monitor the concentration of various impurities at inlet and outlet of fluidized bed granulation dryer
  • Want to measure the impurity concentration in ppb level

Solution from HORIBA

Advantages of APNA-380

  • Continuous monitoring of NO, NO2, NOx in ppb level
    • Chemiluminescence method offers excellent sensitivity, long-term stability, and low zero drift
    • Wide measurement range allows for the measurement of different gas concentrations

  • Simultaneous monitoring of NO, NO2, NOx
    • Optimized internal structure enables high-speed switching between NO and NOx lines, allowing for the simultaneous measurement of NO, NO2 and NOx

  • Reduction of environmental impact and cleaner exhaust gas
    • Utilization of UV lamp for internal ozone generator
    • Catalyzer free thermal ozone decomposer

  • Remote operation function equipped as standard
    • Can be remotely access from PC, tablet or smartphone 
    • Modbus® TCP and RTU communication are equipped as standard. Data can be saved to USB flash drive.

 

*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

Nitrogen Oxides Monitor APNA-380



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