Volume 249, 15 October 2024, 116372
Quantification of API content in pharmaceutical tablets within milliseconds by time-stretch near-infrared transmission spectroscopy
Koji Nakayama a, Junki Sahara b, Masaya Fujimoto a, Yasufumi Yagisawa a, Keiko Kobata b, Hiroyuki Kawagoe b, Aya Ikarashi b, Takuma Yokoyama b, Tomoaki Sakamoto c
a Towa Pharmaceutical Co., Ltd. (Japan), b Ushio, Inc. (Japan), c National Institute of Health Sciences (Japan)
Ushio developed a high-intensity near-infrared time-stretch spectrometer and demonstrated its ability to rapidly and accurately quantify active pharmaceutical ingredient (API) content in tablets. Although transmission measurement is preferred for API quantification, the extremely weak transmitted light requires long integration times, making millisecond-order measurements difficult. To overcome this, a time-division spectroscopy method using a broadband near-infrared pulsed light source was employed, enabling fast and precise measurement of low-transmittance samples. In this study, a measurement time of 3.9 milliseconds per tablet was achieved with quantification performance comparable to conventional Fourier-transform near-infrared spectroscopy (FT-NIR). It was also confirmed that pulsed light irradiation does not affect the tablets.
Future work will focus on accelerating device development toward commercialization and enhancing pharmaceutical reliability.
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