Foreign matter identification from solid dosage forms

Research output: Contribution to journalJournal articleResearchpeer-review

Jari Pekka Pajander, Kenneth Brian Haugshøj, Kathrine Bjørneboe, Pia Wahlberg, Jukka Rantanen

Despite the increased request for robust quality systems, the end product may contain unidentified defects or discoloured regions. The foreign matter has to be monitored, identified and its source defined in order to prevent further contamination. However, the identification task can be complicated, since the origin and nature of foreign matter are various. The aim of this study is to provide an efficient foreign matter identification procedure for various substances possibly originating from pharmaceutical manufacturing environment. The surface or cross-section of the uncoated and coated tablets was analysed by utilization of different analytical techniques, such as light microscopy (LM), scanning electron microscopy in combination with energy dispersive X-ray microanalysis (SEM/EDX), Fourier transform infrared spectroscopy (FT-IR) and time-of-flight secondary ion mass spectrometry (ToF-SIMS). The results indicate that the combination of different analytical techniques proved to be a powerful approach in foreign matter identification. Light microscopy and SEM generate information on the morphology of foreign matter particles. EDX provides elemental analysis, which most often serves as final confirmation of the identification. However, FT-IR can be used to obtain information on the compounds chemical structure and conformation, and ToF-SIMS provides sensitivity in cases, where the entire solid dosage form is contaminated with foreign matter.
Original languageEnglish
JournalJournal of Pharmaceutical and Biomedical Analysis
Volume80
Pages (from-to)116-125
Number of pages10
ISSN0731-7085
DOIs
Publication statusPublished - 5 Mar 2013

ID: 45129792