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. 2016 Jan 5:117:104-8.
doi: 10.1016/j.jpba.2015.08.039. Epub 2015 Aug 30.

Identification, synthesis, isolation and characterization of new impurity in metoprolol tartrate tablets

R Buchi Reddy  1 , Kishor R More  2 , Leena Gupta  1 , Mukesh S Jha  1 , Laki Magar  1
Affiliations

Identification, synthesis, isolation and characterization of new impurity in metoprolol tartrate tablets

R Buchi Reddy et al. J Pharm Biomed Anal. .

Abstract

A new unknown impurity was observed in accelerated stability studies of Metoprolol tartrate tablets. This impurity has been identified, synthesized and characterized through different spectral studies and confirmed as an adduct of lactose and Metoprolol formed by Maillard reaction.

Keywords: Amadori rearrangement; Lactose; Maillard; Metoprolol; Stability.

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