| Fourier Transform near-infrared (FT-NIR) spectroscopy is an integral analytical technology for the pharmaceutical industry used in R&D, pilot scale and manufacturing. FT-NIR has a proven ability to detect changes, both large and small, in physical and chemical parameters of samples. This makes FT-NIR an ideal tool for monitoring materials in the QA/QC lab as well as in-process. Some examples of the utility of FT-NIR spectroscopy for pharmaceutical applications include raw material ID, API quantification in tablets, real-time moisture monitoring and control in fluid bed dryers, particle size analysis and online solids homogeneity determination. Primary methods for critical analytical tasks in pharmaceutical manufacturing are typically labor- or material-intensive or both. Traditional methods for chemical determination or quantification include titrations or HPLC, but both of these techniques are time consuming and expensive. Typical titrations take about 20 minutes while GC or LC runs can take almost as long. In addition, all these methods require disposables such as solvents or columns. FT-NIR spectroscopy is a technique that does not require any disposable items, is fast and reliable, and can be taken into manufacturing areas where substantial cost savings can be realized with online analysis. With the Antaris™ family of NIR analyzers, calibration models that are developed in the lab can be transferred seamlessly to the plant. Due to precision engineering, there is no need to completely recalibrate a new instrument once it arrives onsite. With features like a flex-pivot interferometer, pinned-in-place optics and RESULT™ software, each scan of the instrument is the same as the last making for accurate and precise measurements. | Design of ExperimentInstrument: Antaris MX with cart, integrated touchscreen computer and Barcode reader
Technique: Raw Material ID
Rationale: One of the main benefits of this above configuration for raw material ID is mobility. The Antaris MX is lightweight and has a small footprint. In addition, the integrated computer and a barcode reader allows ultimate flexibility for users doing this type of discrimination analysis anywhere in a goods-in area. The multiple simultaneous scanning ability of the Antaris MX allows multiple samples to be scanned at once significantly increasing productivity.
Samples: A set of five samples of each class of material was scanned to account for any variability in either sample chemistry or morphology. These sample spectra were then loaded into TQ Analyst™ where a SIMCA correlation was used to maximize the discrimination of the available data. • |
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