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Measuring Ingredient-Specific Particle Size Distribution Using Wide-Field Raman Chemical Imaging.*
Particle sizing techniques based on laser scattering, cascade impaction or optical image analysis cannot discriminate between particles of API and those of an excipient or a surfactant. Multi-stage cascade impaction followed by extraction and HPLC analysis is an option, but can be extremely time consuming and labor-intensive and is not very reproducible. Consequently, the development of an efficient ingredient-specific approach is essential for ensuring that all ingredients fall into the proper size range, particularly during the early stage of product development.
The FALCON II Wide-field Raman Chemical Imaging System efficiently collects millions of spectrally unique data points at sub-micron spatial resolution. The particle size distribution of the API in a nasal spray suspension is ultimately determined from the chemical images. A Brightfield Reflectance & Raman fusion image is shown in Figure 1 for both a large image montage as well as two individual fields of view. Representative Raman spectra of the API and excipients are shown in Figure 2. The histogram in Figure 3 shows the distribution of 123 API particles calculated by ChemImage Xpert. The mean size of the API particles were 4.4 ± 3.0 µm.
API particles are clearly distinguishable from those of excipients. The FALCON II system is able to differentiate between and identify the chemical makeup of multiple components in complex mixtures.
Acquisition rates surpass the speed of competing point and line mapping systems. The substantial time and labor savings are ultimately transformed into cost savings and a reduced time to market.
* Work performed in collaboration with the US Food and Drug Administration.
* This application note represents the personal opinions of ChemImage Corp. and does not necessarily represent the views or policies of the US Food and Drug Administration.
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