An improved process for the synthesis of prasugrel hydrochloride with an overall yield of 58%, 99.9% purity, and meeting all other quality requirements is described.
An improved and scalable process for the large-scale production of zafirlukast (Accolate), an important drug for asthma, is discussed along with impurity and scale-up-related issues.
New efficient and convenient approaches have been devised for the synthesis of sitagliptin impurities. As a part of impurity profile study of an antidiabetic drug substance sitagliptin 1, we encountered with six process related impurities. These impurities were detected by utilizing simple techniques such as high performance liquid chromatography (HPLC) and liquid chromatography‐mass spectrometry (LC–MS). All these impurities were synthesized and their presence in the sitagliptin sample was confirmed by co‐injection and matching the retention time with spiked impurities. The formation and control of these impurities during sitagliptin manufacture and synthesis of these impurities is discussed in detail. Synthesis of these impurities was accomplished by utilizing readily accessible starting materials, simple, convenient and concise reaction sequence.
An improved process has been developed for the active pharmaceutical ingredient, ranolazine with 99.9% purity and 47% overall yield (including three chemical reactions and one recrystallization). Formation and control of all the possible impurities is described. All the solvents used in the process were recovered and reused. The unreacted piperazine is recovered as piperazine monophosphate monohydrate salt.
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