Spectroscopy Articles - Latest

FTIR (Fourier Transform Infrared Spectroscopy) process analyzers have been shown to be a convenient and versatile analytical tool for monitoring reactions in real-time during flow chemistry development and manufacture. In this example, on-line FTIR is first applied to a Curtius rearrangement reaction in a batch mode, which provides the chemist with insight into both the mechanisms and kinetics of the chemistry being developed. The results from the experiments conducted in batch mode are then applied to enable the development of the flow chemistry process read more

In today’s global scenario, where the path forward is clearly the advancement in biotechnology, Near Infrared (NIR) spectroscopy has found special applications. NIR is a fast and effective tool for the understanding of the lyophilization process and evaluation of lyophilized materials. Due to its ability to penetrate glass and plastic containers, NIR spectroscopy demonstrates an excellent non-invasive means to analyze lyophilized materials. Infrared technology can not only be used for moisture determination in lyophilized samples but also for in-process control of drug and excipient stability. The technique has been evaluated as a Process Analytical Technology (PAT) tool in lyophilization of biological materials i.e. proteins, polypeptides and monoclonal antibodies. read more

For many biopharmaceutical drug products the last manufacturing step involves freeze-drying. As freeze-drying may be hazardous for the protein’s physical stability, this step can, when not well controlled, transform a product with an acceptable quality into one to be rejected. Knowledge on the protein’s conformational stability during freeze-drying processes is highly desired, as it may facilitate the development of freeze-drying cycles, increase process efficiency and create possibilities for preventing product lost. This paper discusses the suitability of Near-infrared (NIR) and Raman spectroscopy as potential in-line process analyzers for this purpose. read more

Various manufacturing platforms are often investigated during the development of a solid oral dosage form. The final selection of a manufacturing process is primarily based on ensuring critical drug product quality attributes such as physical and chemical stability, dissolution, active ingredient consistency and integrity, and ease of scalability. read more