Monday, January 1, 2018

Novel Analytical Methods to Verify Cleaning Process

The manufacturing suite used for pharmaceutical formulation is often not dedicated to one drug only. Manufacturers must be very careful during the switchover process to ensure that the active pharmaceutical ingredient (API) is completely flushed before moving on to the next formulation. Using charged aerosol detection with HPLC allows us to see every non-volatile that might be left behind. Chromatograms with individual peaks represent API residues in the tank and the peaks indicate concentration. For more information: http://chrom.ms/67ZFF6b

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Pharmaceutical Validation Documentation Requirements

Pharmaceutical validation is a critical process that ensures that pharmaceutical products meet the desired quality standards and are safe fo...