Pharmaceuticals: Residual Impurity Analysis
Residual Solvent Analysis
FT-MRR offers a faster, simpler alternative to the standard USP <467> GC-FID method for analysis of residual solvents in pharmaceutical products and excipients. Whereas the standard method requires extensive calibration standards and 60 minute chromatographic run times, FT-MRR achieves complete selectivity and excellent sensitivity in a 10 minute run without chromatography. The BrightSpec Headspace Module, which can be combined with a CTC PAL autosampler, delivers automation and reproducibility with little operator training.
Mutagenic Impurity Analysis
Mutagenic impurities pose a significant challenge for pharamaceutical analytical chemists, given that they are a health risk even at trace levels. Identification and quantitation of these (often unknown) impurities can be an onerous process. FT-MRR provides fingerprint spectra of impurities based on the three-dimensional moments of inertia, and can be identified through comparison to BrightSpec’s spectral library, or even directly to quantum chemical calculations without a reference standard required. BrightSpec has developed a Thermal Evolution sampling method to release all volatile impurities in a solid sample, which delivers structural identification and quantitation in one measurement. This can dramatically speed up the impurities characterization and control process.
Pharmaceutical: Chiral and Structural Analysis
Chiral Process Monitoring
The chiral purity of a drug is essential to its efficacy and safety, and yet chirality is very challenging to measure by most spectroscopic methods. FT-MRR offers the only analytical technique that can identify and quantify both diastereomers and enantiomers directly in a process flow. The high resolution and selectivity of FT-MRR means that no sample purification or separation is needed – the crude reaction mixture can be injected directly to the BrightSpec spectrometer.
App note coming fall 2017
Rotational spectroscopy is emerging as the gold standard technique for spectroscopic determination of molecular structure, backed by major improvements in instrument design and computational theory. For small-molecule APIs and intermediates, BrightSpec’s FT-MRR technology can identify components on the basis of their three dimensional structures without ambiguity, including resolving conformers, diastereomers, and enantiomers.
App note coming fall 2017
Industrial Gas and Petrochemical: Trace Gas Impurities
Small polar compounds can endanger a chemical process or be a health hazard, even at trace levels, yet they are challenging to monitor, especially in complex matrices. FT-MRR spectroscopy identifies and quantifies molecules through their rotational resonances at high resolution, without matrix interference. The spectrometer characterizes gas mixtures directly and can return quantitative results in seconds.
Research applications of spectroscopy in the microwave to millimeter wave region of the spectrum are rapidly growing, including studies of molecular structure and bonding, reaction kinetics and dynamics, and astrochemistry, among others. BrightSpec provides an instrument product line for researchers that enables them to start their research faster – while leaving maximum flexibility for incorporating new sample chambers and methods.
Molecular rotational spectroscopy is typically not included in the undergraduate instrumentation curriculum. BrightSpec is seeking to change that. The capabilities of rotational spectroscopy to determine molecular structures in the gas phase, study reaction kinetics, and perform quantitative analyses of gas mixtures make it an excellent way to introduce students to the principles of spectroscopy in analytical chemistry.