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Ensuring raw material quality: this month's expert examines the most appropriate technique for checking raw material quality.

Article Excerpt
What technique would you recommend for quality checking of raw materials?

Near-infrared (NIR) spectroscopy is a well-known tool for identifying raw materials in the pharmaceutical industry. It is a very sensitive, nondestructive technique using overtones and combination bands of fundamental vibrations derived from the mid-infrared. Spectra can be used to distinguish closely related materials such as API polymorphs and excipient analogues. Analysis time is only a few seconds and samples can be analysed in disposable glass vials or directly with a fibre optic probe.

However, NIR spectroscopy can be used for more than just raw material identification. With current industry trends using PAT and Quality by Design (QbD) initiatives, building knowledge and reducing risk in production processes are becoming increasingly important. Many companies are focusing research on unit operations such as blending and tableting, but there is much to be gained by revisiting the quality of raw materials entering the process.

Raw materials can now be identified and tested for manufacturing suitability. Most unit operations are physical processes. Physical properties of raw materials affect the manufacturing process when used in an inflexible recipe, resulting in poor quality products. Changes in particle size or polymorphism will influence flow properties and moisture uptake,...

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