FIELD: chemistry.
SUBSTANCE: invention relates to a novel S-crystalline form of ivabradine hydrochloride, a process for its preparation, and a pharmaceutical composition thereof. S-crystalline form of ivabradine hydrochloride has an X-ray powder diffraction pattern having characteristic peaks at positions expressed in 2-theta degrees: 8.5±0.2, 11.5±0.2, 14.6±0.2, 15.3±0.2, 16.1±0.2, 17.1±0.2, 17.5±0.2, 17.8±0.2, 18.6±0.2, 19.3±0.2, 21.6±0.2, 21.9±0.2, 27.2±0.2, and, according to DSC, has an endothermic peak of crystalline transformation as a characteristic peak at 111.6°C, and an exothermic crystalline transformation peak as a characteristic peak at 136.9°C, and a melting decomposition peak as a characteristic peak at 194.9°C.
EFFECT: products based on the S-crystalline form are easy to dry, have high purity and stability, and are convenient for long-term storage, without special requirements for temperature and humidity.
8 cl, 5 tbl, 7 ex
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