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Analytical methods for the evaluation of melamine contamination.

Authors
Type
Published Article
Journal
Journal of Pharmaceutical Sciences
1520-6017
Publisher
Elsevier
Publication Date
Volume
103
Issue
2
Pages
539–544
Identifiers
DOI: 10.1002/jps.23812
PMID: 24327168
Source
Medline
Keywords
License
Unknown

Abstract

There is an urgent need for the analysis of melamine in the global pharmaceutical supply chain to detect economically motivated adulteration or unintentional contamination using a simple, nondestructive analytical technique that confirms the extent of adulteration in a shorter time period. In this work, different analytical techniques (thermal analysis, X-ray diffraction, Fourier transform infrared (FT-IR), FT-Raman, and near-infrared (NIR) spectroscopy) were evaluated for their ability to detect a range of melamine levels in gelatin. While FT-IR and FT-Raman provided qualitative assessment of melamine contamination or adulteration, powder X-ray diffraction and NIR were able to detect and quantify the presence of melamine at levels as low as 1.0% w/w. Multivariate analysis of the NIR data yielded the most accurate model when three principal components were used. Data were pretreated using standard normal variate transformation to remove multiplicative interferences of scatter and particle size. The model had a root-mean-square error of calibration of 2.4 (R(2) = 0.99) and root-mean square error of prediction of 2.5 (R(2) = 0.96). The value of the paired t test for actual and predicted samples (1%-50% w/w) was 0.448 (p < 0.05), further indicating the robustness of the model.

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