NIRS combined with appropriate mathematical models and pattern recognition techniques allows analysis of a wide variety of sample types rapidly. Second, NIRS is a non-destructive technique which avoids complex sample preparation by chemical or physical processes. In fact, both solid and liquid samples in different types of packaging stored under different conditions can all be tested without complex pretreatment because of the better penetrability of fiber optics used in NIRS. Third, it provides acceptable accuracy in both qualitative and quantitative analysis to meet the requirements of QC and preliminary screening
The manufacture of pharmaceutical products from raw material identification to the measurement of content uniformity of dosage forms can be assisted by the implementation of NIR methods.
The United States Food and Drug Administration (FDA) and European Union health guidelines have increased the workload and rigor associated with receiving inspection, blending, and content assay. With the advent of 100% container testing for receiving inspection of raw materials in Europe and Canada, NIR technology can reduce the time and skill level required to meet the increased challenge of compliance.
With the PAT (Process Analytical Technology) initiative, the FDA aims to bring about an increase in efficiency in pharmaceutical production, including a trend away from final checks towards real-time process analysis and control.
The initiative requires rapid analytical techniques that allow a comprehensive online and inline monitoring of the manufacturing process. Common pharmaceutical applications using NIR include: receiving inspection of excipients and active pharmaceutical ingredients (API), blend uniformity, granulation, drying and coating, and particle size analysis.
Additionally, NIR is an invaluable tool for the detecting of counterfeit drug products and the determination of water and residual solvent content. NIRS is described in the European (Ph.Eur.) and Japanese (JP) Pharmacopoeia as well as in the United States Pharmacopeia (USP).