2021 FDA Science Forum
The Analysis of Unknown Particles Isolated from Compounded Pharmaceutical Products Using Optical Microscopy, FT-IR and Raman Micro Spectroscopy.
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Contributing OfficeOffice of Regulatory Affairs
Abstract
There are certain instances when a medical professional may need to prescribe a patient a pharmaceutical preparation not commercially available. In this case, they may turn to a compounding pharmacy to obtain the necessary preparation. Both sterile and non-sterile products may be prepared by compounding pharmacies and in either case they require specialized equipment, facilities, training and expertise. Sterile products include ophthalmic, inhalation and injectable products while non-sterile products include solid dosage forms or topical liquids. Although care and precautions are taken, contamination of compounded pharmaceutical products may occur. One type of contamination includes the presence of unknown particles. The sources of these unknown particles include but are not limited to environmental contamination, packaging components and formulation interactions and errors. The identification of these unknown particles is important to determine the source of contamination for corrective action, but more importantly, to protect the patient’s health.
Depending on the product matrix, the selection of the proper isolation and preparation method is important to maintain the integrity of the unknown particle(s). Once the unknown particle(s) are isolated, the choice of instrumental or wet chemical analysis is important in determining their identity. Solid state analysis techniques such as optical microscopy, molecular micro spectroscopy (UV-VIS, FT-IR and Raman) and even mass spectrometry (direct analysis in real time, DART) can be used to derive useful chemical information. These techniques provide morphological and chemical information about the unknown particles which can be useful in determining their origin and allow for a portion of the unknown particles to be retained for further analysis.
This poster will describe three sample preparation methods useful in isolating unknown particles from liquid matrices; filtration, centrifugation and physical removal. Unknown particles observed in five different compounded pharmaceutical preparations (inhaler cartridges, injectable vials and a topical solution) were isolated using these methods. The unknown particles isolated were analyzed using optical microscopy and FT-IR and Raman micro spectroscopy. The results of the unknown particles analyzed indicated three different possible sources of contamination; environmental, packaging components or formulation interactions and errors.
