Chemical maps show the distribution of active pharmaceutical ingredients with excipients, and are supported by quantitative data to calculate API concentration, particle size, and number of particles
The Sapphire from Spectral Dimensions represents a new benchmark in NIR chemical imaging for applications in pharmaceutical manufacturing, QA/QC and research and development, says Chromsolutions.
The latest Sapphire system coupled with Isys software is rapidly able to produce chemical 'maps' of the components in a tablet or other solid dosage forms.
Chemical maps show the distribution of active pharmaceutical ingredients with excipients.
These maps are also supported by quantitative data that is able to calculate API concentration, particle size and total number of particles.
Other applications include include blend monitoring, formulation research and development, root cause analysis, clinical trials pack screening, QA/QC, tablet pressing anomalies and polymorph screening and identification.
Using the Sapphire, NIR chemical imaging can significantly reduce development time and improve time to market for new chemical entities, it is claimed.
Through the use of root cause analysis and QC it can help reduce manufacturing problems that result in QC failure and improve manufacturing efficiency.
For example the Sapphire instrument can completely image an 8x8mm tablet in three minutes, collecting 81,000 spectra during that time.
Sapphire is constructed with mainly solid state components and very few moving parts, which means it works reliably in the harshest of laboratory environments, says Chromsolutions, adding that the combination of rugged instrumentation and easy to use software makes this a very useful tool for pharmaceutical QC and QA environments, where minimal operator involvement but rapid generation of results is a requirement.
