An Efficient, Scalable Process for Benzphetamine Hydrochloride
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- 作者：Chinmoy Pramanik ; Kiran Bapat ; Ashok Chaudhari ; Mukund G Kulkarni ; Rangarao Kolla ; Srinivasarao Sompalli ; Narendra K. Tripathy ; Mukund K. Gurjar
- 刊名：Organic Process Research & Development
- 出版年：2014
- 出版时间：April 18, 2014
- 年：2014
- 卷：18
- 期：4
- 页码：495-500
- 全文大小：277K
- 年卷期：v.18,no.4(April 18, 2014)
- ISSN：1520-586X
文摘
Commercial manufacturing of benzphetamine hydrochloride along with its impurity profiling is disclosed. Deoxygenation of pseudoephedrine is reported with 100% retention by shielding the amine group as its tert-butyl carbamate, which is very straightforward to eliminate at the end. Four unknown process-related impurities are isolated from the samples of final API and characterized on the basis of their NMR and mass spectral analysis. Structures of the isolated impurities are confirmed by independent syntheses and coinjecting with the isolated one.