Raman spectrum measurements are possible under humidity conditions.
The stability testing guidelines state that stability tests, which determine the shelf life of formulations and storage conditions for pharmaceuticals under various environmental factors such as temperature, humidity, and light, are necessary tests for drug approval applications. Therefore, using Raman spectroscopy, which allows for non-contact measurements and is used for identifying polymorphs similar to powder X-ray diffraction, we focused on one of the environmental factors, "humidity," and analyzed and evaluated the crystal transition from hydrate to anhydrous form of caffeine, a model formulation, under humidity conditions using Raman spectra. This demonstrated that Raman spectroscopy is effective for observing the crystal forms of active pharmaceutical ingredients under humid conditions.
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basic information
It is possible to control humidity arbitrarily between 5% and 85% relative humidity. Under humidity-controlled conditions, it is possible to obtain the Raman spectrum of substances non-contactly. Real-time measurements can be performed, allowing for the temporal analysis and evaluation of phase transitions in the crystalline forms of substances.
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It is known that changing the crystal form of an active ingredient administered orally as a solid dosage form can improve solubility, enhance bioavailability, and alter storage conditions. The polymorphism of pharmaceuticals, as well as pseudopolymorphs such as hydrates and anhydrates, significantly affects the quality of pharmaceuticals in formulations. Furthermore, stability testing guidelines state that stability tests, which determine the shelf life of formulations and storage conditions for pharmaceuticals under various environmental factors such as temperature, humidity, and light, are necessary for drug approval applications. Therefore, using Raman spectroscopy, which allows for non-contact measurement and is used to identify crystal polymorphs similar to powder X-ray diffraction, we focused on "humidity," one of the environmental factors, and analyzed and evaluated the crystal transition from hydrate to anhydrate of the model formulation caffeine under humidity conditions through Raman spectra, demonstrating that Raman spectroscopy is effective for observing the crystal forms of active ingredients under humid conditions.
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Our company supports the establishment of measurement methods, analytical techniques, and testing methods (analytical methods) using Raman spectroscopy, centered on vibrational spectroscopy, which can be utilized in quality control areas such as acceptance testing, from research and development fields like the evaluation of the physical properties of pharmaceutical raw materials and the dispersion state of solid formulation particles. We provide support for the development of analytical conditions, testing method settings, and validation. Please feel free to contact us if you have any requests.