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STABILITY STUDIES: A REVIEW
Article · December 2013
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Arunachalam A. et al. / Asian Journal of Pharmaceutical Analysis and Medicinal Chemistry. 1(4), 2013, 184 - 195.
Available online: October - December 184
Review Article ISSN: 2321-0923
STABILITY STUDIES: A REVIEW
A. Arunachalam
*1
, M. Shankar
2
*1
Department of Pharmaceutics, Asmara College of Health Sciences, School of Pharmacy, Asmara, Eritrea, Africa.
2
Department of Pharmaceutical Chemistry, Seven Hills College of Pharmacy, Tirupati, A P, 517562, India.
INTRODUCTION
INTRODUCTION
Stability testing of pharmaceutical products is a
complex set of procedures involving considerable
cost, time consumption and scientific expertise in
order to build in quality, efficacy and safety in a
drug formulation. Scientific and commercial
success of a pharmaceutical product can only be
ensured with the understanding of the drug
development process and the myriad tasks and
milestones that are vital to a comprehensive
development plan. The most important steps during
the developmental stages include pharmaceutical
analysis and stability studies that are required to
determine and assure the identity, potency and
ABSTRACT
The stability studies is one of the very important parameters of pharmaceutical products. Stability assessment
and shelf-life prediction is usually a major focus of a pharmaceutical scientist’s attention in the development
of all dosage forms. It is important in the development of small molecule drug products as well, particularly
given the importance of the physical state of the drug in determining stability characteristics. Stability testing
is utilized for formulated product to prediction of shelf life, determine proper storage conditions and suggest
labeling instructions.
KEYWORDS
Stability Studies, Shelf Life, Expirary Date, Storage Conditions, CPMP Guidelines and ICH Guidelines.
Author for correspondence:
A. Arunachalam,
Department of Pharmaceutics,
University of Asmara,
Asmara College of Health Sciences,
School of Pharmacy, Asmara, Eritrea, Africa.
Email: [email protected]
Asian Journal of Pharmaceutical Analysis
and
Medicinal Chemistry
Journal home page:

Arunachalam A. et al. / Asian Journal of Pharmaceutical Analysis and Medicinal Chemistry. 1(4), 2013, 184 - 195.
Available online: October - December 185
purity of ingredients, as well as those of the
formulated products
1
. Stability of a pharmaceutical
product may be defined as the capability of a
particular formulation in a specific
container/closure system to remain within its