Development of validated stability-indicating assay methods—critical review
1
Department of Pharmaceutical Analysis, National Institute of Pharmaceutical Education and Research, Sector 67, S.A.S. Nagar, 160 062, Punjab, Mohali, India.
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2
Department of Pharmaceutical Analysis, National Institute of Pharmaceutical Education and Research, Sector 67, S.A.S. Nagar, Mohali 160 062, Punjab, India
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Publication type: Journal Article
Publication date: 2002-06-01
scimago Q2
wos Q2
SJR: 0.628
CiteScore: 6.4
Impact factor: 3.1
ISSN: 07317085, 1873264X
PubMed ID:
12049968
Drug Discovery
Spectroscopy
Pharmaceutical Science
Clinical Biochemistry
Analytical Chemistry
Abstract
This write-up provides a review on the development of validated stability-indicating assay methods (SIAMs) for drug substances and products. The shortcomings of reported methods with respect to regulatory requirements are highlighted. A systematic approach for the development of stability-indicating methods is discussed. Critical issues related to development of SIAMs, such as separation of all degradation products, establishment of mass balance, stress testing of formulations, development of SIAMs for combination products, etc. are also addressed. The applicability of pharmacopoeial methods for the analysis of stability samples is discussed. The requirements of SIAMs for stability study of biotechnological substances and products are also touched upon.
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Bakshi M., Singh S. Development of validated stability-indicating assay methods—critical review // Journal of Pharmaceutical and Biomedical Analysis. 2002. Vol. 28. No. 6. pp. 1011-1040.
GOST all authors (up to 50)
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Bakshi M., Singh S. Development of validated stability-indicating assay methods—critical review // Journal of Pharmaceutical and Biomedical Analysis. 2002. Vol. 28. No. 6. pp. 1011-1040.
Cite this
RIS
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TY - JOUR
DO - 10.1016/S0731-7085(02)00047-X
UR - https://doi.org/10.1016/S0731-7085(02)00047-X
TI - Development of validated stability-indicating assay methods—critical review
T2 - Journal of Pharmaceutical and Biomedical Analysis
AU - Bakshi, Monika
AU - Singh, Saranjit
PY - 2002
DA - 2002/06/01
PB - Elsevier
SP - 1011-1040
IS - 6
VL - 28
PMID - 12049968
SN - 0731-7085
SN - 1873-264X
ER -
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BibTex (up to 50 authors)
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@article{2002_Bakshi,
author = {Monika Bakshi and Saranjit Singh},
title = {Development of validated stability-indicating assay methods—critical review},
journal = {Journal of Pharmaceutical and Biomedical Analysis},
year = {2002},
volume = {28},
publisher = {Elsevier},
month = {jun},
url = {https://doi.org/10.1016/S0731-7085(02)00047-X},
number = {6},
pages = {1011--1040},
doi = {10.1016/S0731-7085(02)00047-X}
}
Cite this
MLA
Copy
Bakshi, Monika, and Saranjit Singh. “Development of validated stability-indicating assay methods—critical review.” Journal of Pharmaceutical and Biomedical Analysis, vol. 28, no. 6, Jun. 2002, pp. 1011-1040. https://doi.org/10.1016/S0731-7085(02)00047-X.