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Abstract

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

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