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).