Small Molecules

Thermal analysis is used to investigate active compounds' chemical and physical properties.

Using thermogravimetric analysis (TGA) or differential scanning calorimetry (DSC), purity, stability, polymorphism, and compatibility of the API can be characterized.

UV-Vis spectrophotometry is commonly used for the quantitative analysis of small molecules.

Titration has long been a standard method utilized to evaluate the level of active ingredients in pharmaceuticals and the content and purity of medicine additives used in the manufacturing of medicinal compounds.

In-situ Fourier transform infrared (FTIR) spectroscopy is widely used in process development due to its direct, nondestructive measurement principle.

This direct measurement permits real-time determination of key reaction parameters such as kinetics, mechanism, endpoint, transient intermediates, and reaction pathway. 

Process analytic sensors are widely used in process development and API manufacturing to monitor synthesis parameters in-line, allowing decisions on product quality to be made in situ, without relying on offline quality assurance and control.

In-situ Raman is routinely used in process development for all the same reasons as in-situ FTIR for reaction monitoring, but it also enables in-situ measurement of the desired compound polymorphic form.

The desired product form is vital to knowing and reproducibly controlling it, not only for scale-up but also to ensure it is the correct form. Other forms may not have comparable efficacies for their intended purposes and can also be toxic to humans.