Thermal analysis and FTIR in supplier qualification: Evidence of impurities and risks associated with handling

Abstract

Magistral formulations allow for dose customization according to patient needs. The qualification of raw material suppliers is essential to ensure the efficacy and safety of the final product. Despite regulations, deviations, losses, and contamination may occur during the process. Thus, this study analyzed supplier qualification, highlighting the importance of characterization tests to ensure high-quality raw materials and, consequently, good pharmaceutical products. Four raw materials commonly used in compounding pharmacies were evaluated: hyaluronic acid, ketoconazole, hydroquinone, and papain, all susceptible to changes caused by factors such as temperature, humidity, and light. Samples were obtained from two compounding pharmacies in Recife, Brazil, between February and March 2024. The characterization tests included Differential Scanning Calorimetry, Thermogravimetric Analysis, and Fourier Transform Infrared Spectroscopy. The results showed impurities in some samples, especially those of papain, indicating structural modifications. On the other hand, the samples of hyaluronic acid, ketoconazole, and hydroquinone showed adequate purity. Therefore, it is essential to perform physicochemical control of active pharmaceutical ingredients intended for compounding to confirm their respective purities and ensure the safety and efficacy of the medications produced, ultimately safeguarding patient health.