In drug development, the active pharmaceutical ingredient (API) is the drug component that provides the health benefits.
The purpose of adding APIs is to cause pharmacological activity or direct effects in the diagnosis, treatment, cure, mitigation or prevention of diseases, according to the FDA. This is the reason why Pharmaceutical Manufacturers are mainly selected for their API, so their production process is crucial.
Typically, APIs are manufactured by fermentation processes, chemical synthesis and isolation and recovery from natural sources. Irrespective of the process used for API production, a constant pressure is placed on product quality with minimal costs within the competitive environment of API production.
Bruker Optics spectroscopy solutions can assist Manufacturers in attaining this superior level of product quality while keeping costs to the minimum. Bruker Optics products provide vital insights into API synthesis reactions and they are perfect for both traditional organic synthesis and biotechnology techniques that employ micro-organisms.
Bruker Optics’ Fourier Transform Near-Infrared (FT-NIR) Spectrometers
FT-NIR spectrometers from Bruker Optics are ideal solutions for effective API production. These instruments are used to identify and quantify compounds and chemicals within the API, to confirm that it consists of the right ingredients to deliver an end product of superior quality.
Sample preparation is not needed with this technique of spectroscopy. Also, the technique is non-destructive and requires no dangerous chemicals. As a result, this technique is fast, safe and reliable for API production.
The Matrix-F FT-NIR Spectrometer from Bruker Optics
The Matrix-F FT-NIR spectrometer offers real-time direct measurements of API chemicals and compounds, which results in better understanding and improved control of the pharmaceutical production process.
The Matrix-F is designed to measure solids, liquids and slurries using fiber optic probes specifically engineered for all sample types and process geometry. The Matrix-F is the only multiplexed, process spectrometer that can provide contactless measurement of powders and solids and measure slurries and liquids using the same instrument.
Built for reliability and easy maintenance, the Matrix-F FT-NIR spectrometer has user-exchangeable consumable parts that do not need any realignment of the optics. Service of the spectrometer can also be accomplished quickly to minimize disruption to the manufacturing process.
The MPA FT-NIR Spectrometer from Bruker Optics
The MPA FT-NIR spectrometer is a multi-purpose analyzer that allows users to test different techniques before selecting the ideal technique for the API production process.
Large sample quantities can be tested with a press of a button, so the MPA FT-NIR spectrometer is a precise and quick tool that provides a non-destructive analysis of the API compounds and chemicals, saving costs by minimizing reagent use and shortening time.
The MPA FT-NIR spectrometer is simple to operate with easy measurement modes, customizable workspaces and wizards to guide the user through setup. The instrument has a smart display, which notifies the user if the measurement failed or passed.
Bruker Optics supplies a wide variety of solutions that can help with all phases of the drug production process, including API production.
This information has been sourced, reviewed and adapted from materials provided by Bruker Optics.
For more information on this source, please visit Bruker Optics.