Most pharmaceutical products are specified to be essentially free of visible particles, and there are limits on the number of allowable sub-visible particles. The FDA requires that contamination problems be fully investigated in a timely fashion. Utilizing microscopical examination coupled with sample isolation, preparation, and analytical methods optimized for small particles, this Pharmaceutical Analysis course teaches an analytical approach to successfully identify particulate contamination for regulatory compliance.
The overall analytical approach for the identification of contaminant particles is outlined at the beginning of the course. The analysis plan includes sample examination, gathering of background information concerning the sample, and particle isolation. Analytical methods taught include: stereomicroscopy, polarized light microscopy (PLM), Fourier transform infrared spectroscopy (FTIR), and Raman. The course emphasizes pharmaceutical microscopy to identify the following typical particle types: metals, minerals, fibers, hairs, glass, polymers, chemicals, excipients, and botanicals.
In addition to using actual samples in this Pharmaceutical Analysis course, each student has access to the free online McCrone Atlas of Microscopic Particles. The Atlas contains PLM and SEM images, and descriptions; and EDS, IR and Raman spectra for over 60 fully-characterized pharmaceutical contaminants.
See below for course outline and additional information.
Students are expected to successfully complete a variety of tasks in the form of hands-on exercises, laboratory exercises, identifications of unknowns, and quizzes. In addition, the students are required to have 100% attendance during the course, participate in class, complete a student evaluation form and pre and post course assessment forms.
The student is notified at the end of the course whether or not they have successfully completed the requirements of the course based on:
Upon successfully meeting these requirements, a student is awarded a certificate of completion and CEU credits, if available. Those who have not successfully passed the course requirements do not receive a certificate or CEU credits.