Ciurczak details 2

Spectroscopic Hyperspectral Chemical Imaging

Emil W. Ciurczak, Doramaxx Consulting

The original practice of spectroscopy involved destroying a sample to analyze it: we grind, mix with a solvent, extract the analyte, bring the (filtered) solution to a known volume, then place it in a cuvette for scanning. This may show the amount(s) of analyte(s) in a single sample, but the vast majority of information has been lost: hardness, distribution of analyte(s), particle size(s) of analytes, polymorphic form(s) of the analytes, and so forth.

When reflection near-infrared spectroscopy was developed, solid samples (e.g., tablets, capsules, foodstuffs, etc.) were able to be examined. By applying Chemometrics, we could now analyze (predict) individual chemical entities and macro-parameters (hardness, density) as well as discovering the potential changes in crystallinity and morphology of the chemicals of interest without destroying the sample. But, we are still seeing the average values and still have no idea of distribution of actives.

With chemical imaging, we generate a 3-D “hypercube” of data. That is we have a 2-D portrait of the sample (displayed as thousands or tens of thousands of pixels), with each pixel also containing a full spectrum (NIR, IR, Raman, or fluorescence) of the material in that pixel. This allows the analyst to show where each component is located: how much, size of clusters, morphology of EACH CRYSTAL, and much more.

We will look at the hardware and software available for these measurements and examine a number of applications, showing the wealth of data available as well as seeing how many uses spectroscopy can have in both end uses and in-process controls. The applications in medicine, drug development, food, and so on will be discussed.

 

Brief Biography of Emil W. Ciurczak

Emil W. Ciurczak has advanced degrees in Chemistry from Rutgers and Seton Hall Universities, has been in the pharmaceutical industry since 1970, performing method development on most types of analytical equipment. In 1983, he introduced NIR spectroscopy to pharmaceutical applications. He also consults for numerous instrument companies. His research is largely pharmaceutical applications of NIR where he has published over five dozen articles in refereed journals, over 250 magazine columns, and presented over 200 technical papers.

Since 2005, Emil has been Contributing Editor for Pharmaceutical Manufacturing magazine (wrote a column for Spectroscopy; 1987-2007) and for Contract Pharma magazine since 2013. He has written and edited several texts and chapters: “Handbook of NIR Analysis” (1st, 2nd, and 3rd editions, 4th in progress), “Pharmaceutical and Medical Applications of NIRS” (1st & 2nd editions), “Molecular Spectroscopy Workbench,” and chapters on NIR applications to life sciences. Emil sits on several magazine editorial boards, is active in SAS, is a founder of the Council for NIRS, and was the 2002 chair for IDRC (Chambersburg Conference).

He has been teaching (college adjunct) since 1979: Stevens Tech, College of St. Elizabeth, Hood College, and Mount St. Mary’s College; as well as short courses (in NIR, Raman, and PAT/QbD) for the ACS, CfPA (US and Europe), PTI, SPIE, ASSA, and other organizations.

Emil is a consultant in the field of NIR (lab and process applications) and holds more than a dozen patents for NIR-based devices and software. He consults with various pharmaceutical companies, instrument manufacturers, and the FDA. He was a member of the PAT sub-committee (Validation) for the FDA and member of the PAT Expert Committee for the USP. He was the 2004 recipient of the EAS Achievements in NIR Award.