Rivaroxaban ethylamino analog (2HCl salt) is a characterized process-related impurity observed during rivaroxaban manufacture and stability studies. This impurity exhibits distinct mass spectral and chromatographic behavior, facilitating identification by LC-MS/MS and HPLC-UV methods. Analytical profiling indicates potential formation via ethylamine incorporation or salt transformation under acidic conditions, making it a relevant target for impurity profiling, method validation, and stability-indicating assays. Control strategies include specification setting, limit establishment and use as a reference material for forced degradation studies and batch release testing. Detailed impurity data support regulatory submissions and quality risk assessments for rivaroxaban drug substance manufacturing.
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To provide the best experiences, we use technologies like cookies to store and/or access device information. Consenting to these technologies will allow us to process data such as browsing behavior or unique IDs on this site. Not consenting or withdrawing consent, may adversely affect certain features and functions.
Functional
Always active
The technical storage or access is strictly necessary for the legitimate purpose of enabling the use of a specific service explicitly requested by the subscriber or user, or for the sole purpose of carrying out the transmission of a communication over an electronic communications network.
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The technical storage or access is necessary for the legitimate purpose of storing preferences that are not requested by the subscriber or user.
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The technical storage or access that is used exclusively for statistical purposes.The technical storage or access that is used exclusively for anonymous statistical purposes. Without a subpoena, voluntary compliance on the part of your Internet Service Provider, or additional records from a third party, information stored or retrieved for this purpose alone cannot usually be used to identify you.
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![1,5,6,7,8,9-Hexahydro-5,9-methanoimidazo[4,5-h][3]benzazepine hydrochloride](https://veeprho.com/wp-content/uploads/2022/12/Rivaroxaban-Nitrosamine-Impurity-II.png "1,5,6,7,8,9-Hexahydro-5,9-methanoimidazo[4,5-h][3]benzazepine hydrochloride")
