An application note is now available from Spectral Dimensions that shows how near infrared chemical imaging (NIR-CI) adds a completely new dimension to conventional NIR spectroscopy
The US FDA has released guidelines advising the use of new technologies to monitor processes taking place during the manufacture of pharmaceuticals.
The process analytical technology (PAT) initiative promotes the use of techniques that enable the monitoring of critical process parameters during pharmaceutical manufacturing.
Historically the FDA has focused on purity and potency as a measure of product quality.
Looking to the future more examination of physical processes will be necessary.
For example what do small changes such as blending, drying, coating or other manufacturing steps have on the final dosage form? A tablet is not usually made up of one material but is a composite of active pharmaceutical ingredients, fillers, binders, disintegrants, lubricants and other material.
One of the problems associated with pharmaceutical manufacture is that a relatively straightforward process can produce widely varying therapeutic performance depending on how the ingredients are distributed in the final dosage form.
Near infra red chemical imaging is a powerful non destructive technique which enables the investigator to quickly unravel the possible complexities and problems that may occur during pharmaceutical manufacturing.
The Sapphire near infra red chemical imaging system is well placed to meet the requirements of the PAT initiative not least because of it ease of use, very few moving parts and accordant robustness, says Spectral Dimensions.
