Detecting contamination in pharmaceutical products
Particulate matter contamination in pharmaceuticals may affect product performance and pose severe risks to patients. If an unknown material is found, manufacturers need to know the contamination source and take necessary measures to guarantee product integrity and meet regulatory compliance.
Particulate identification and analysis are crucial steps towards resolving suspected contamination of products.
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The article provides an understanding of contaminant analysis techniques, such as:
- Light Microscopy
- Fourier Transform Infrared Spectroscopy (FTIR) Spectroscopy
- Scanning Electron Microscopy (SEM) coupled with Energy Dispersive X-Ray Spectroscopy (EDS)
It also provides a case study where such techniques were applied to identify unknown particulate material on two sets of tablet samples showing dark, discolored particles on their surfaces, giving you an opportunity to see how contaminant analysis can help you ensure product safety and maintain regulatory compliance.