Open AccessRaman Spectroscopy for Quantitative Analysis in the Pharmaceutical Industry
Author(s) -
José Izo Santana da Silva de Jesus,
Raimar Löbenberg,
Nádia Araci BouChacra
Publication year - 2020
Publication title -
journal of pharmacy and pharmaceutical sciences
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.497
H-Index - 78
ISSN - 1482-1826
DOI - 10.18433/jpps30649
Subject(s) - process analytical technology , pharmaceutical industry , pharmaceutical manufacturing , drug development , biochemical engineering , food and drug administration , process (computing) , risk analysis (engineering) , pharmaceutical drug , nanotechnology , computer science , data science , drug , engineering , business , medicine , work in process , pharmacology , materials science , operations management , operating system
Raman spectroscopy is a very promising technique increasingly used in the pharmaceutical industry. Due to its development and improved instrumental versatility achieved over recent decades and through the application of chemometric methods, this technique has become highly precise and sensitive for the quantification of drug substances. Thus, it has become fundamental in identifying critical variables and their clinical relevance in the development of new drugs. In process monitoring, it has been used to highlight in-line real-time analysis, and it has been used more commonly since 2004 when the Food and Drug Administration (FDA) launched Process Analytical Technology (PAT), integrated with the concepts of Pharmaceutical Current Good Manufacturing Practices (CGMPs) for the 21st Century. The present review presents advances in the application of this tool in the development of pharmaceutical products and processes in the last six years.