Identification of hematite particles in sealed glass containers for pharmaceutical uses by Raman microspectroscopy

Raman microspectroscopy has been shown to enable the identification of micro-particles inside sealed glass containers for pharmaceutical use without any sample preparation. Raman spectra were collected from unknown particles with a maximum size of 1mm, adsorbed on the inner surface of ampoules. The...

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Vydáno v:Journal of pharmaceutical and biomedical analysis Ročník 54; číslo 4; s. 866 - 868
Hlavní autoři: Caudron, E., Tfayli, A., Monnier, C., Manfait, M., Prognon, P., Pradeau, D.
Médium: Journal Article
Jazyk:angličtina
Vydáno: Amsterdam Elsevier B.V 25.03.2011
Elsevier
Témata:
Adsorption
Analysis
Analytical, structural and metabolic biochemistry
Biological and medical sciences
Cardioplegic Solutions
containers
Drug Contamination - prevention & control
Drug Packaging
Ferric Compounds - analysis
Fundamental and applied biological sciences. Psychology
General pharmacology
glass
Glass - chemistry
Hematite
magnetite
manufacturing
Medical sciences
Microchemistry - methods
Particle identification
Particle Size
Pharmaceutical container
pharmaceutical industry
Pharmaceutical Solutions
Pharmacology. Drug treatments
process control
product quality
Quality Control
Raman spectroscopy
Spectrum Analysis, Raman
Surface Properties
Technology, Pharmaceutical
Hematite
Pharmaceutical container
Particle identification
Raman spectroscopy
Particle
Container
Optical microscopy
Glass
Qualitative analysis
Microspectrophotometer
Raman spectrometry
Iron III Oxides
ISSN:0731-7085, 1873-264X, 1873-264X
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Shrnutí:Raman microspectroscopy has been shown to enable the identification of micro-particles inside sealed glass containers for pharmaceutical use without any sample preparation. Raman spectra were collected from unknown particles with a maximum size of 1mm, adsorbed on the inner surface of ampoules. The particles were clearly identified as primarily hematite with traces of magnetite by their characteristic Raman spectral bands. The presence of this deposit was attributed to the projection of iron oxides during the manufacturing process. These oxide particles were not detected by the quality control process of the glass manufacturer, showing that in-process quality controls failed to detect this problem. Particle identification by Raman microspectroscopy appears to be a selective, rapid and reliable analytical procedure for quality control and assurance in the pharmaceutical industry. Identification of the particles was also helpful for evaluating the nature of the contaminant and enables consequences for the toxicological aspects of final product quality to be managed.
Bibliografie:http://dx.doi.org/10.1016/j.jpba.2010.10.023
ObjectType-Article-1
SourceType-Scholarly Journals-1
ObjectType-Feature-2
content type line 23
ISSN:0731-7085
1873-264X
1873-264X
DOI:10.1016/j.jpba.2010.10.023