Structure elucidation and quantification of impurities formed between 6-aminocaproic acid and the excipients citric acid and sorbitol in an oral solution using high-resolution mass spectrometry and nuclear magnetic resonance spectroscopy

Author:

Schou-Pedersen Anne Marie V.,Cornett Claus,Nyberg NilsORCID,Østergaard Jesper,Hansen Steen Honoré

Funder

Danish Health and Medicines Authority

Bioneer-FARMA

Publisher

Elsevier BV

Subject

Clinical Biochemistry,Spectroscopy,Drug Discovery,Pharmaceutical Science,Analytical Chemistry

Reference28 articles.

1. Interactions and incompatibilities of pharmaceutical excipients with active pharmaceutical ingredients: a comprehensive review;Bharate;J. Excip. Food Chem.,2010

2. Drug–excipient interactions;Crowley;Pharm. Tech. Eur.,2001

3. International Conference on Harmonization. Impurities in new drug products Q3B R2,2006

4. Application of mass spectrometry for metabolite identification;Ma;Curr. Drug Metab.,2014

5. Advances in bioanalytical LC–MS using the Orbitrap™ mass analyzer;Scigelova;Bioanalysis,2009

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