The polymorphic stability of a drug substance is
a very important topic in the pharmaceutical industry. Differential scanning
calorimetry, thermogravimetric analysis with the support of X-ray powder diffraction
and infrared spectroscopy were used as screening techniques for testing structural
changes of zolpidem tartrate hydrate stored under different conditions. Obtained
data suggested that first structural changes occurred at the temperature of
25°C after 2 months of storage. DSC analysis showed that there was a two-step
process of water elimination and lack of a phase transition in the temperature
range from 130 to 170°C in comparison with an initial sample.
Keywords drug substance - DSC - infrared spectroscopy (IR) - polymorphic stability - thermogravimetric analysis (TG/SDTA) - X-ray powder diffraction (XRPD) - zolpidem tartrate