12/02/2005 • Focus on Products at Analytica • Laboratory appliances

New from Malvern Instruments – advanced near infrared chemical imaging for solid dosage forms

Following the acquisition of Spectral Dimensions Inc. in July 2006, Malvern Instruments has added powerful NIR (near infrared) chemical imaging systems to its portfolio. The company’s NIR-CI 2450 incorporates the latest technology for chemical imaging .

Chemical imaging in the Pharmaceutical Industry

To develop and manufacture pharmaceutical products that have characteristic and reproducible performance, it is critical to optimize sample components, and understand their spatial interactions. Because it provides a window into these traits, Chemical imaging of solid dosage forms is used increasingly in the pharmaceutical industry for applications ranging from formulation development to determining content uniformity to assessing coating thickness.

This non-destructive analytical approach combines traditional near infrared spectroscopy with microscopic and macroscopic imaging. Just a single rapid measurement enables the identification and spatial localization of chemical species in a sample that can be correlated with a sample performance metric, such as dissolution.

The NIR-CI 2450 system from Malvern Instruments
The NIR-CI 2450 from Malvern Instruments is designed especially for chemical imaging applications in formulation, QA/QC and production. Collection of sample images across the entire NIR spectral range, from 1200 to 2450 nm, enables data acquisition with the best possible chemical specificity. This makes the system ideal for assessing the characteristics of tablets, granules, powder blends and others that have spatially complex arrangements of different chemical species.

Highly flexible ISys software turns images into quantitative metrics through a powerful, versatile, and comprehensive suite of multivariate and statistical methods. Once developed, data processing strategies can be automated into discrete processing macros for reproducible results. Additionally the NIR-CI 2450 offers the technical capability to achieve 21CFR Part 11 compliance once the required procedural and administrative controls are in place.
The result is reliable, validatable, quantitative characterization of the chemical and physical properties of a variety of complex solid-state materials and products.

The system incorporates several features that greatly increase its capabilities, both for R&D applications, and particularly for QA/QC analyses.

An easily configurable field of view allows imaging of single or multiple samples to suit individual requirements. The ability to change rapidly between imaging small areas at high resolution (micro mode) and large areas at low resolution (macro mode) permits screening for areas of interest followed by more detailed, closer examination.

Rapid data acquisition enables the capture of high fidelity sample images, across the whole NIR spectral range or only at critical wavelengths. Specific wavelengths or wavelength ranges can be targeted for the fastest possible operation with no compromise on performance.

Fully automated sequential analysis of multiple samples is possible with an optional programmable sample stage. "Macro" functions in ISys data analysis software complement and automatically analyze the sequence of captured images.

Details of Malvern’s full range of chemical imaging solutions and their applications are available on HYPERLINK "http://www.malvern.com/chemical-imaging" www.malvern.com/chemical-imaging

More about the NIR-CI2450:

http://www.malvern.co.uk/LabEng/products/sdi/nir-ci_2450/nir_analyzer_nir-ci_2450.htm

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