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FT-NIR analysis for pharmaceutical raw material identification sector - Chemical & Pharmaceuticals - Pharmaceuticals
Within the globalized pharmaceutical raw material supply chain, there is an increasing public health concern of raw material adulteration, contamination, or mislabeling, especially with recent incidents such as the adulteration of heparin. This has driven regulatory bodies to update their guidelines. Chapter 5.33 of the latest GMP guidelines for Medicinal Products for Human Use, provided by the European Commission (EC), entitled "Eudralex," specifies that "there should be appropriate procedures or measures to assure the identity of the contents of each container of starting material1." This means that all raw materials used in pharmaceutical manufacture must be analyzed and this has to be done for every single container. The raw materials not only have to be identified, but also tested to ensure they meet certain specifications.
Traditionally, multiple methods have been used for individual raw material analysis, including spectroscopic methods like UV-Vis and mid-infrared, chromatographic methods like TLC, HPLC, GC, and wet chemical analysis methods. Each method takes at least five minutes. This is very time consuming, with several steps required for adding different materials. In addition, the cost of consumables (chemicals, solvents, etc.) contributes to the increased cost of the final product.
Near-infrared spectroscopy (NIR), on the other hand, is rapid, non-destructive, and can be used for most organic compound identification and quantitative analysis. Samples can be non -invasively analyzed directly through plastic bags or glass vials, with no sample preparation and no cross contamination. The measurement takes a few seconds to return both qualitative and quantitative analyses. Since 2002, a number of guidelines, such as US Pharmacopoeia, European Pharmacopoeia, and EMEA, have advised the use of NIR spectroscopy as a universal method for raw material identification and assay.
Fifteen of most commonly used pharmaceutical excipients and active ingredients from different vendors and batches were collected and placed in 25 mm glass vials. NIR spectra were collected using a QuasIR™ 3000 (Galaxy Scientific, Nashua, NH, USA) as shown in Figure 1. The vials containing the samples were placed on top of the integrating sphere sample window and spectra were collected through the bottom of the glass vial. Each sample was measured three times using 8 cm" resolution and 10 scans.
Spectral Sage™ software was used for data collection. For raw material identification, the QC compare method was used, which is based on correlation coefficient differences between the test and reference spectra. Figure 2 displays the original spectra of the excipients and active ingredients. The original spectra were pre-processed using a Savitzky-Golay first derivative. The first derivative spectra of the 15 materials were plotted in Figure 3.
