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

作者：Rodrigo Muzzio Cristian; Gabriel Dini Nicolas; Daniela Simionato Laura

来源：Brazilian Journal of Pharmaceutical Sciences, 2011, 47(2): 289-297.

DOI：10.1590/S1984-82502011000200010

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

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 (R(pred)(2)), yielded by the pre-treatments and calibration method proposed, was 0.233% (w/w) and 0.994, respectively.

• 出版日期2011-6