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Predicting pharmaceutical manufacturing changes using molecular laser-induced breakdown spectroscopy and chemometrics

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Predicting pharmaceutical manufacturing changes using molecular

laser-induced breakdown spectroscopy and chemometrics

Doucet, François R.; Faustino, Patrick J.; Tourigny, Martine; Lyon, Robbe C.;

Sabsabi, Mohamad

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Predicting Pharmaceutical Manufacturing Changes using

Molecular Laser-Induced Breakdown Spectroscopy and

Chemometrics

François R. Doucet

1

, Patrick J. Faustino

2

, Martine Tourigny

3

, Robbe C. Lyon

2

and

Mohamad Sabsabi

1

1

National Research Council of Canada (IMI), Boucherville (QC), Canada

2

Division of Product Quality Research, CDER, US FDA, Silver Spring, MD, USA

3

Pharma Laser, Boucherville (QC), Canada

In many pharmaceutical manufacturing applications, Laser-Induced Breakdown

Spectroscopy (LIBS) makes possible at-line rapid measurements of many

formulation ingredients as well as the possibility of stand-off analysis, situ,

in-line and on in-line process monitoring. These capabilities make LIBS an attractive

PAT sensor technology that can be introduced virtually everywhere in the

pharmaceutical manufacturing process. Molecular Laser-Induced Breakdown

Spectroscopy (MO-LIBS) uses the molecular band emission of small diatomic

fragments and chemometrics to establish predictive model that allow quantitative

measurements. This innovative approach allows a complete simultaneous

formulation ingredients analysis as well as the prediction of pharmaceutical

manufacturing changes. The results obtained in this work highlight the potential

for MO-LIBS to be more widely applied to process monitoring and quality control

of pharmaceutical products.

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