Assessing mass balance in pharmaceutical drug products: New insights into an old topic
1
Small Molecule Design and Development, Eli Lilly and Company, Indianapolis, IN 46285, USA.
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2
Department of Chemistry, Hillsdale College, 33 East College St. Hillsdale, MI 49242, USA
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Publication type: Journal Article
Publication date: 2013-09-01
scimago Q1
wos Q1
SJR: 2.089
CiteScore: 18.6
Impact factor: 12.0
ISSN: 01659936, 18793142
Spectroscopy
Analytical Chemistry
Abstract
Mass balance is an important concept in pharmaceutical development, but it often proves challenging to assess accurately. This article explores the various methods by which mass balance can and should be measured, expressed, and evaluated in conjunction with degradation chemistry. Causes of mass-balance issues and potential solutions are summarized, as are the advantages and the disadvantages of various detection strategies. The importance of reactants other than the parent drug, reaction stoichiometry, response factors, and assay variability are discussed, and recommendations for obtaining reliable and informative mass-balance information are provided.
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Total citations:
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Citations from 2024:
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(55%)
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GOST
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Baertschi S. W. et al. Assessing mass balance in pharmaceutical drug products: New insights into an old topic // TrAC - Trends in Analytical Chemistry. 2013. Vol. 49. pp. 126-136.
GOST all authors (up to 50)
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Baertschi S. W., Pack B. W., Hyzer C. H., Nussbaum M. Assessing mass balance in pharmaceutical drug products: New insights into an old topic // TrAC - Trends in Analytical Chemistry. 2013. Vol. 49. pp. 126-136.
Cite this
RIS
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TY - JOUR
DO - 10.1016/j.trac.2013.06.006
UR - https://doi.org/10.1016/j.trac.2013.06.006
TI - Assessing mass balance in pharmaceutical drug products: New insights into an old topic
T2 - TrAC - Trends in Analytical Chemistry
AU - Baertschi, Steven W.
AU - Pack, Brian W
AU - Hyzer, Cherokee Hoaglund
AU - Nussbaum, M.A.
PY - 2013
DA - 2013/09/01
PB - Elsevier
SP - 126-136
VL - 49
SN - 0165-9936
SN - 1879-3142
ER -
Cite this
BibTex (up to 50 authors)
Copy
@article{2013_Baertschi,
author = {Steven W. Baertschi and Brian W Pack and Cherokee Hoaglund Hyzer and M.A. Nussbaum},
title = {Assessing mass balance in pharmaceutical drug products: New insights into an old topic},
journal = {TrAC - Trends in Analytical Chemistry},
year = {2013},
volume = {49},
publisher = {Elsevier},
month = {sep},
url = {https://doi.org/10.1016/j.trac.2013.06.006},
pages = {126--136},
doi = {10.1016/j.trac.2013.06.006}
}