Development of a nondestructive assay method using Raman spectroscopy in the pharmaceutical production process of a freeze‐dried injection with gemcitabine as active pharmaceutical ingredient. (28th September 2021)

• Record Type: Journal Article
• Authors: Kim, Jaejin; Han, Janghee; Woo, Young‐Ah
• Is Part Of: Bulletin of the Korean Chemical Society. Volume 42:Number 12(2021)
• Page Start: 1692
• Page End: 1698
• Publication Date: 2021-09-28
• Subjects: freeze‐drying -- gemcitabine -- process analytical technologies -- Raman spectroscopy -- real‐time monitoring; Chemistry -- Periodicals; 540.5
• DOI: 10.1002/bkcs.12407
• Languages: English
• ISSNs: 0253-2964

Abstract

Abstract: Freeze‐dried injectable drugs based on gemcitabine are mainly used as anticancer drugs for pancreatic cancer. High‐performance liquid chromatography (HPLC) analysis is mainly used to analyze the active pharmaceutical ingredient (API) content in the pharmaceuticals prepared in this way. While the HPLC method has high accuracy, it has the disadvantage that it cannot measure all of the large numbers of products produced due to the long measurement time. To solve this problem, a Raman spectrometer was installed in the pharmaceutical production process to measure the API content of all products. After installing a Raman spectrometer in the pharmaceutical production process, the verified quantitative model was used to measure API content in real time. A total of 4500 vials from three batches were tested, and the averages of each of the three batches were 100.0%, 100.2%, and 99.7%. Abstract : Real‐time monitoring of pharmaceutical ingredients using Raman spectroscopy.