Synthesis and characterization of new related substances of the antiarrhythmic drug dronedarone hydrochloride

Solid-State Form Characterization of Riparin I

“…The results indicated that batches displayed obvious differences in morphology due to the different molecular arrangements of solid-state riparin I. These differences in particle size and morphology can be caused by polymorphism or by changes in the crystal growth conditions, the nature of the crystallization solvent, the degree of supersaturation, or the presence of impurities [ 2 ]. Differences in the crystal habit may strongly influence particle orientation and modify the flowability, packing, compressibility, and dissolution characteristics [ 1 ].…”

“…The 13 C-NMR spectra of batches are shown in Figure 8 . The solid forms can be clearly distinguished based on their high-resolution ssNMR spectra [ 1 , 2 ]. The data show a well-resolved signal, indicating that there is only one molecule in the crystalline asymmetric for RIP-1, RIP-4, and RIP-5.…”

“…The diversity of solid-state forms that drugs may attain is typically governed by different factors such as the synthetic route and reaction conditions; the quality of the starting materials, reagents, and solvents; and the purification steps for the end product [ 2 , 3 ]. Batch-to-batch variations of the concentration of impurities during the crystallization of organic products are known to lead to significant changes in the quality of the final crystal [ 4 , 5 ].…”