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Volume 9
Journal of Analytical & Bioanalytical Techniques
Page 16
Notes:
conference
series
.com
September 19-20, 2018 Singapore
World Congress on
Mass Spectrometry and Analytical Techniques
Mass Spectra & Analytika 2018
September 19-20, 2018
Elucidation of unknown pharmaceutical degradation products: Structures and pathways
A
lgorithmfor the elucidation of several unknown degradation products shown in the stability studies of Active Pharmaceutical
Ingredients (APIs) and drug products, including structures and degradation pathways has been proposed. Collision
Activated Dissociation (CID) fragments of APIs and their related intermediates, received using high-performance Liquid
Chromatography-tandem Mass Spectrometry (LC-MS/MS) were achieved firstly. Accordingly, Multiple Reaction Monitoring
(MRM) ion pairs and fragmentation pathways can be developed secondly. Meanwhile, considering the feasibility of secondary
degradation products, core chemical structures that might occur in common in the degradation products were deduced. MRM
ion pairs together with related biotransformation scanning (i.e. oxidation (+O, +2O), dehydration (-H
2
O, -(H
2
O)
2
), carbon
dioxide removal and HOAc removal) and Information-Dependent Acquisition (IDA) in the target HPLC retention regions
were evaluated and compared thoroughly. Finally, unknown degradation products needed to be verified by the stability test
samples. Countermeasures, such as pattern of stable isotopic peaks, kinetics studies and interference factors existed in reagents,
manufacturing process raw materials and environment such as plasticizer and catalysts were investigated. Unexpected products
and interaction between excipients were also identified.
Biography
Kung Tien Liu has completed his PhD from Department of Chemistry, National Taiwan University, Taiwan and has worked in Institute of Nuclear Energy Research
(INER) more than 29 years. He also concentrates his major activities on the GxP related compliance issues for the development and applications of pharmaceuticals.
Currently, he is the Deputy Director of Administration Office, Pharmaceutical B U, Everlight Chemical Industrial Co. (ECIC). He has been published more than 40
papers, patents and book chapters.
kungtien@ecic.com.twKung Tien Liu
Everlight Chemical Industrial Corporation, Taiwan
Kung Tien Liu, J Anal Bioanal Tech 2018, Volume 9
DOI: 10.4172/2155-9872-C2-030