Abstract
The present disclosure relates to processes for the preparation of high purity 7-cyclopentyl-N,N-dimethyl-2-{[5-(piperazin-1-yl) pyridin-2-yl]amino}-7H-pyrrolo [2,3-d]pyrimidine-6-carboxamide or its pharmaceutically acceptable salts substantially free of nitrosamine impurities, other genotoxic and carcinogenic impurities below threshold concentration. The structure of formula-1 is shown as below:
Formula-1.
The present disclosure also describes the process for the pharmaceutical composition and its process for the preparation of Ribociclib or its pharmaceutically acceptable salts.
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Recommended Citation
MSN Laboratories Private Limited, R&D Center; Hyderabad, India; Srinivasan Thirumalai Rajan; Nithiyanandam Ravi Kumar; Seetharaman Sritharan; Irukuvajjula Venkata Subrahmanya Vithal; Gade Srinivas Reddy; Thota Siva Prasad; Yeole Prashant Ramesh; Kesari Sai Manoj Krishna; Thippireddy Purna Chandrasekhar Reddy; Ragam Naveen; Bhatraju Daveedu and Pulijala Karunakar., "A process for the preparation of substantially pure 7-cyclopentyl-N,N-dimethyl-2-{[5-(piperazin-1-yl) pyridin-2-yl]amino}-7H-pyrrolo[2,3-d]pyrimidine-6-carboxamide or its pharmaceutically acceptable salts", Technical Disclosure Commons, ()
https://www.tdcommons.org/dpubs_series/12197