Determination of moisture content in lyophilized mannitol through intact glass vials using NIR micro-spectrometers

Authors

  • Cristian Rodrigo Muzzio Hitec S.R.L; Research and Development Department
  • Nicolás Gabriel Dini Hitec S.R.L; Research and Development Department
  • Laura Daniela Simionato University of Buenos Aires; Faculty of Pharmacy and Biochemistry; Pharmaceutical Technologies Department Quality Control Laboratory

DOI:

https://doi.org/10.1590/S1984-82502011000200010

Keywords:

Near-infrared spectroscopy, Lyophilization, Multivariate analysis, Moisture content, Mannitol, Micro-spectrometer

Abstract

Determination of moisture content in lyophilized solids is fundamental to predict quality and stability of freeze-dried products, but conventional methods are time-consuming, invasive and destructive. The aim of this study was to develop and optimize a fast, inexpensive, noninvasive and nondestructive method for determination of moisture content in lyophilized mannitol, based on an NIR micro-spectrometer instead of a conventional NIR spectrometer. Measurements of lyophilized mannitol were performed through the bottom of rotating glass vials by means of a reflectance probe. The root mean standard error of prediction (RMSEP) and the correlation coefficient (R²pred), yielded by the pre-treatments and calibration method proposed, was 0.233% (w/w) and 0.994, respectively.

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Published

2011-06-01

Issue

Vol. 47 No. 2 (2011)

Section

Articles

License

All content of the journal, except where identified, is licensed under a Creative Commons attribution-type BY.

The on-line journal has open and free access.

How to Cite

Determination of moisture content in lyophilized mannitol through intact glass vials using NIR micro-spectrometers . (2011). Brazilian Journal of Pharmaceutical Sciences, 47(2), 289-297. https://doi.org/10.1590/S1984-82502011000200010