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 under humidification conditions of a model formulation using Raman spectra, demonstrating that Raman spectroscopy is effective for observing the crystal form of active pharmaceutical ingredients under humidification 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-contact. Real-time measurement is possible, allowing for the temporal analysis and evaluation of the transition of the crystal form of substances.
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Applications/Examples of results
It is known that changing the crystal form of an active ingredient administered orally as a solid formulation 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 the drug in formulations. Additionally, 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 measurements and is used for the identification of 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 a model formulation, caffeine, under humidity control conditions using Raman spectra. This demonstrated that Raman spectroscopy is effective for observing the crystal form of the active ingredient under humidity control conditions.
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Company information
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 from research and development fields such as the evaluation of the physical properties of pharmaceutical raw materials and the dispersion state of solid dosage form particles to quality control fields such as acceptance testing. We provide support for the construction of analytical conditions, testing method settings, and validations. Please feel free to contact us if you have any requests.
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