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Virtual Journal for Biomedical Optics

Virtual Journal for Biomedical Optics

| EXPLORING THE INTERFACE OF LIGHT AND BIOMEDICINE

  • Editor: Gregory W. Faris
  • Vol. 3, Iss. 9 — Sep. 8, 2008

Raman Mapping of Low-Content Active-Ingredient Pharmaceutical Formulations. Part II: Statistically Optimized Sampling for Detection of Less Than 1% of an Active Pharmaceutical Ingredient

Slobodan Šašić and Mark Whitlock

Applied Spectroscopy, Vol. 62, Issue 8, pp. 916-921 (2008)


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Abstract

Several tablets are prepared with two forms of an active pharmaceutical ingredient (API) of which one (less than 1% w/w) is considered undesirable. The presence of this component is tested for by Raman microscopy in a series of mapping experiments. These experiments are conducted with a statistically based sampling routine in which the number of spectra to collect across the whole surface of a tablet is set so as to theoretically ensure spectral detection of the low-concentration form. Such experiments are then repeated a number of times to achieve ∼95% confidence that the strictly limited number of sampling points suffice to detect the low-concentration form and that Raman microscopy is technically a reliable method for analytical analysis of this type.

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Vol. 3, Iss. 9 Virtual Journal for Biomedical Optics

Citation
Slobodan Šašić and Mark Whitlock, "Raman Mapping of Low-Content Active-Ingredient Pharmaceutical Formulations. Part II: Statistically Optimized Sampling for Detection of Less Than 1% of an Active Pharmaceutical Ingredient," Appl. Spectrosc. 62, 916-921 (2008)
http://www.opticsinfobase.org/vjbo/abstract.cfm?URI=as-62-8-916


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