Drug Stability Testing

NIS Molecule

The thermal stability of liposomes, lipid nanoparticles, and other nanoparticles often reflects their in vivo stability and drug release characteristics. These properties can be adversely influenced and affected by the added components, including the drug itself, making it important to understand the structure and dynamics of the system as a whole. Stability is a critical quality attribute that must be controlled during drug development and manufacturing, through to final product use.

Transmission Electron Microscopy (TEM), and in particular, cryo-TEM allows for the direct visualization of particles and a comprehensive characterization of morphology to monitor and ensure product stability. The direct analysis and characterization of nanoparticles with cryo-TEM allows for monitoring the effect of changes to the size, shape, lamellarity, morphology, from external variables such as product contamination and storage on particle stability. Cryo-TEM can also help evaluate the influence of storage conditions, including pH, temperature, and time, on the morphology on samples such as lipid nanoparticles.

NIS helps visualize critical quality attributes directly

Imagine what you can achieve by gaining a more thorough way of monitoring and controlling critical quality attributes such as product stability during manufacturing and process validation. NanoImaging Services makes this possible with our nanoparticle characterization services. Our expert scientists help navigate you to the best product fast, saving you time, money, and ultimately creating a better performing final drug product.

Frequently Asked Questions

Cryo-EM microscopic image of Drug Stability Testing
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