Evaluation of the Manufacturing Process for Pharmaceuticals by Using Micro-imaging Analysis

Abstract

Raman spectroscopy is a spectroscopic technique used to observe vibrational, rotational, and other low-frequency modes in a system. Raman spectroscopy is commonly used in chemistry to provide a structural fingerprint by which molecules can be identified. This spectroscopy has the advantage of being able to rapidly and non destructively measure a sample without pretreatment. Application of this method in the pharmaceutical field can qualitatively or quantitatively evaluate active ingredients and additives in drug substance and preparation. It can also be used for evaluation of physical state such as crystal form and degree of crystallinity. In addition, distribution evaluation of active ingredients and additives in the dosage form can be carried out by using a microscopic technique. Further, by using an optical fiber, spectrum measurement can be performed without sampling, for a sample at a place distant from the main body of the device; it is possible to use powerful means for conducting manufacturing process management of pharmaceuticals. In this paper, the fundamental Raman spectra and application examples of formulation evaluation was explained.