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Critical Practical Aspects in the Application of Liquid Chromatography-Mass Spectrometric Studies for the Characterization of Impurities and Degradation Products

Mallikarjun Narayanam, Tarun Handa, Parul Sharma, Shalu Jhajra, Praveen Kumar Muthe, Pavan Kumar Dappili, Ravi P Shah, Saranjit Singh

J Pharm Biomed Anal. 2014 Jan;87:191-217.

PMID: 23706957

Abstract:

Liquid chromatography-mass spectrometry (LC-MS) is considered today as a mainstay tool for the structure characterization of minor components like impurities (IMPs) and degradation products (DPs) in drug substances and products. A multi-step systematic strategy for the purpose involves high resolution mass and multi-stage mass studies on both the drug and IMPs/DPs, followed by comparison of their fragmentation profiles. Its successful application requires consideration of many practical aspects at each step. The same are critically discussed in this review.

Chemicals Related in the Paper:

Catalog Number Product Name Structure CAS Number Price
AP152100453 [(S)-(−)-1-(4-Nitrophenyl)-2-pyrrolidinemethyl]acrylate [(S)-(−)-1-(4-Nitrophenyl)-2-pyrrolidinemethyl]acrylate 152100-45-3 Price
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