Published 2021-08-16
Keywords
- NIR,
- Polymorphism,
- Active pharmaceutical ingredients
Copyright (c) 2018
This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.
Abstract
This work explores the comprehensive development of a near infrared (NIR) spectroscopic analytical technique for high-throughput applications for the determination of pharmaceutical raw materials and excipients in a pharmaceutical formulation. Advancements in the NIR spectrometry as quality and process control tool have been discussed. The applications include analyses of different types of samples, manufacturing and identification of active pharmaceutical ingredients based on specified experimental design. The samples were measured in diffusion or reflectance mode in a fourier-transform NIR spectrometer. Additionally, chemometric software was employed for quantitative interpretation of bands. The spectrometry can be utilized for identification of raw materials, their size, polymorphism and blend homogeneity.
References
- Reich, Gabriele, Near-infrared spectroscopy and imaging: Basic Principles and pharmaceutical applications, Advanced Drug Delivery Reviews, 10.1016/j.addr.2005.01.020
- FOSS NIR systems – A guide to Near Infrared Spectroscopic analysis
- EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, Brussels, 03 October 2005
- EMEA, Note for Guidance on the Use of NIR Spectroscopy by the Pharmaceutical Industry and the Data Requirements for New Submissions and Variations, The European Agency for the Evaluation of Medicinal Products, 20 February 2003
- D. Kealey and P. J. Haines, “Instant notes on Analytical Chemistry”, Section E (E10 & E11), BIOS Scientific Publishers Limited,ISBN 185996 1894, 2002.
- K. A. Bakeev, “Near-Infrared Spectroscopy as a Process analytical tool Part 1 & 2, Spectroscopy” 18(11)November 2003
- Pasquini, celio, “Near Infrared Spectroscopy: fundamentals, practical aspects and analytical applications”. J. Braz. Chem. Soc., 2003, vol.14, n.2, pp.198-219. ISSN 0103-5053.
- European Pharmacopoeia, 2.2.40. Guideline on the use of Near Infrared Spectroscopy (NIRS) by the pharmaceutical industry and the data requirements for new submissions and variations, 20 January 2012.
- USP <1119> Near Infrared Spectrophotometry.
- Gabriele Reich, “Near-infrared spectroscopy and imaging: Basic principles and pharmaceutical applications”, Advanced Drug Delivery Reviews, vol.57, 1109-1143, 2005.