Samples of reactively-dyed wool were obtained from a range of manufacturers and distributors and “digested” by alkaline hydrolysis to yield colored solutions. Results demonstrate that thin layer chromatographic analysis of reactive dyes yields important additional information, over and above that obtained from techniques such as comparison microscopy and visible light microspectrophotometry. Colored solutions obtained from single fibers were analyzed by thin layer chromatography (TLC) and reproducible results were obtained from a range of fiber lengths.
The purpose of this study was to develop a method of qualitatively predicting the most likely degradants in a formulation or probing specific drug-excipient interactions in a significantly shorter time frame than the typical 1 month storage testing. In the example studied, accelerated storage testing of a solid dosage form at 50 degrees C, the drug substance SB-243213-A degraded via the formation of two oxidative impurities. These impurities reached a level of 1% PAR after 3 months. Various stressing methods were examined to try to recreate this degradation and in doing so provide a practical and reliable method capable of predicting drug-excipient interactions. The technique developed was able to mimic the 1-month's accelerated degradation in just 1 hr. The method was suitable for automated analysis, capable of multisample stressing, and ideal for use in drug-excipient compatibility screening.
Enzymatic digestion of cotton fibres dyed with reactive dyes produces coloured solutions. These are not true dye extracts but they are nonetheless amenable to separation and analysis by thin layer chromatography.
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