Quality control of pharmaceutical impurities
As quality control specialists inspect drug tablets, capsules and other forms of medication on the pharmaceutical production line, they are on the lookout for contaminants that enter into these drugs. To ensure the quality of these medications, they’re required to investigate and document any pharmaceutical impurities according to good manufacturing practices (GMP) in compliance with the FDA’s Title 21 CFR Part 11 guidelines.
When quality control specialists discover a contaminant, they typically send these samples to a third-party lab for analysis. Unfortunately, it can take days or weeks to obtain results, sometimes holding up the release of a product lot. Moreover, these analyses can be expensive when laboratories follow the guidelines required for GMP and CFR Part 11 compliance.
Measuring elemental impurities in pharmaceutical products
With a scanning electron microscope (SEM) that combines energy dispersive X-ray spectroscopy (EDS) into a single system, pharmaceutical companies can take these analyses in-house and dramatically reduce the time and expense required to get the results they need.
Our Thermo Scientific Phenom Desktop SEMs are easy-to-use instruments with a small footprint that fits into most laboratories. These SEMs are simple to use, even for novice users. They integrate EDS for quick and robust elemental analysis, and they provide data within minutes using software that’s CFR Part 11 compliant.
Using a Phenom Desktop SEM, pharmaceutical companies can easily move to a specific location on a drug capsule or tablet and perform EDS to determine the chemical composition of a contaminant.
Quality control with Phenom Desktop SEM
Using a Phenom Desktop SEM, researchers can quickly load a sample into the SEM, navigate to a specific location on a drug capsule or tablet and perform EDS to identify the chemical nature of the contaminant.
Since the analysis is non-destructive, it works well as part of workflows that might include other chemical techniques such as Fourier transform infrared spectroscopy, enabling users to identify nearly any particulate found during quality control.
Outsourcing SEM-EDS analyses of pharmaceutical samples often slows down the pace at which pharmaceutical medications enter the market during the R&D phase, and the manufacturing process during the quality assurance phase. With a Phenom Desktop SEM such as a Phenom ProX or Phenom XL G2, pharmaceutical companies can reduce the time it takes to perform these analyses from days to minutes, while lowering the costs of their overall manufacturing process.
Part of our Three Reasons Why You Should Use a Desktop SEM for Drug Development blog series.
For more reasons why you should use a desktop SEM for drug development, see our previous blog posts about how researchers use these instruments to evaluate the distribution of active pharmaceutical ingredients on excipients and optimize pharmaceutical formulations. Also, please visit our Desktop Scanning Electron Microscopes webpage.
Willem van Zyl is an application engineer at Thermo Fisher Scientific.