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 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.
University Paris-Sud, Groupe de Chimie Analytique de Paris-Sud, School of Pharmacy, 5 rue Jean Baptiste Clément, Châtenay-Malabry, France. eric.caudron@u-psud.fr
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Caudron
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Tfayli
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Monnier
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Manfait
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Prognon
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Pradeau
D000327:Adsorption; D002314:Cardioplegic Solutions; D004340:Drug Contamination / Q000517:prevention & control; D004349:Drug Packaging; D005290:Ferric Compounds / Q000032:analysis*; D005898:Glass / Q000737:chemistry*; D008832:Microchemistry / Q000379:methods; D010316:Particle Size; D019999:Pharmaceutical Solutions; D011786:Quality Control; D013059:Spectrum Analysis, Raman; D013499:Surface Properties; D013678:Technology, Pharmaceutical
D002314:Cardioplegic Solutions; D005290:Ferric Compounds; D019999:Pharmaceutical Solutions; C000499:ferric oxide