It is effective for measuring the Raman spectrum of samples with uneven dispersion of components.
In 2019, Raman spectroscopy was included in the seventeenth revision of the Japanese Pharmacopoeia as "Raman Spectral Measurement Method." This spectroscopy is known to be effective for the quantitative evaluation of active ingredients in a non-contact and non-destructive manner. In recent years, in addition to reflection methods, there have been numerous reports indicating its effectiveness in transmission methods and in evaluating the polymorphism of active ingredients. While there are reports suggesting that near-infrared spectroscopy is effective for process management, particularly in the quantification of active ingredients, there are also reports indicating that it is difficult to quantitatively evaluate active ingredients that are unevenly dispersed. Therefore, we conducted an evaluation and examination of the practicality of a wide-area Raman probe capable of collecting Raman scattered light from a broad range of areas for the quantitative evaluation of multiple crystal forms of active ingredients.
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basic information
In this experiment, a model formulation containing 20% indomethacin as the active ingredient and 80% lactose as an additive was prepared. After varying the content of the crystal forms (a, r) of indomethacin and physically mixing the active ingredient with the additive, tablets were prepared using a tablet press. The usefulness of the wide-area probe was evaluated using the R² values obtained from the calibration curves generated with a commonly used 1/2-inch standard probe and the wide-area probe. For spectral measurements, an All IN One (Marqmetrix Inc. WA U.S.A.) equipped with an excitation laser wavelength of 785 nm was used, with a spectral resolution of 6 cm⁻¹, an exposure time of 0.1 seconds, and an accumulation of 10 scans. The measurement range was from 100 to 3200 cm⁻¹. Data processing, including baseline correction, and PLS2 analysis were performed using Grams AI and IQ version 9.3 (Thermo Fisher Scientific Inc. MA U.S.A.). The analysis range was from 1726 to 1550 cm⁻¹, and PLS2 with Leave-One-Out validation was used to obtain the calibration curve.
Price information
From 700,000 yen (excluding tax). Prices may vary. Please check each time.
Price range
P4
Delivery Time
※1 to 2 months after receiving the order
Applications/Examples of results
Identification of crystal polymorphs, non-destructive and non-contact testing of pharmaceutical formulations, quantitative evaluation of crystal forms in formulations.
Detailed information
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We will conduct sample measurements connected to the Marmqetrix All IN ONE Raman spectrometer. The measurable area has a diameter of approximately 7mm, allowing for the measurement of averaged Raman spectra even for samples with unevenly distributed components.
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It connects to Marqmetrix's ALL IN One for use. The focal length is approximately 7 cm, allowing for non-contact and non-destructive measurement of solid and liquid samples in opaque bottles.
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 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.