Microtrace scientists have been conducting foreign particle analyses on pharmaceutical products and devices for over four decades. Over that period we have seen nearly every type of material and compound from hairs and fibers, to rust and stains, to excipients and precipitates of the original product material. Microtrace maintains a DEA license that permits us to accept and analyze all classes of controlled substances. Should you require a 222 Form, please contact us.
Microtrace specializes in foreign matter identifications and assistance with sourcing investigations. Be it a tablet, lyophilized product, drug solution, or raw material, Microtrace has the experience and expertise to locate, isolate, and identify any type of foreign matter. Due to the wide range of clients that we work with, in both industrial and forensic capacities, our expertise and familiarity with materials extends far beyond the results of a computer generated hit list produced from a spectral search. Combining our experience in light and electron microscopy with chemical analysis through microchemistry and vibrational spectroscopy, we are able to provide specific identifications of virtually any material, including hair (animal and human), fibers (synthetic and natural), polymers, metals, animal and insect parts, skin cells, and body fluids. When necessary, our work is conducted in a clean room environment to ensure that external contamination is not introduced.
Precipitates in Solution
Even the finest precipitates that are noted in solutions can be isolated, characterized, and identified. Immiscible phases such as silicone oils can also be identified and differentiated from solids such as silica nanoparticles. In many cases, the high resolution examination of particles reveals inclusions (particles within particles), which can help to explain the nucleation processes leading to particle formation.
As nanoparticles become more commonly utilized in pharmaceuticals, the significance of distribution issues as well as sub-micron contamination becomes significant. Microtrace scientists have experience working, characterizing, and identifying a wide variety of nanoparticles.
The composition of some pharmaceutical solutions can be mildly or acutely corrosive to the containers. Sample processing can hasten this process causing delamination in the vials. The fine size of such particulate matter can require study by high resolution scanning electron microscopy or transmission electron microscopy, which can provide morphological, size, and compositional information.
Particle Size and Counts
Microscopical measurements (both manual and automated) of particle size, particle counts, and particle size distributions are conducted on a wide range of samples from different environments. In contrast to light scattering measurements, microscopy can provide information about the identity of the particles identified as well as the true particle size. This can be particularly helpful when multiple particle types are encountered.
Stains and Residues
Stains on tablets, discolorations, and residues on vials, even when present in seemingly minute amounts can be isolated and identified. Due to our microanalytical methods, it is generally possible to consume only a minimal amount of the material to ensure that residue remains, in the event that future analyses are required.
Related standardized methods: ASTM E1298