Abstract
Stability is an essential factor of quality, safety and efficacy of a drug product. The objective of stability study is to determine the shelf life, the time period of storage at a specified condition within which the drug product still meets its established specifications. Stability study is of three types that is physical, chemical and microbial stability. Various factors like oxygen, water, temperature, pH, moisture, light and concentration affect the stability. Present work aims to represent the stability testing (ST) requirements of International Conference on Harmonization (ICH), different regulatory agencies like, World Health Organization (WHO), Association of South East Asian Nations (ASEAN) and European Agency for Evaluation of Medicinal and Health Products (EMEA) and difference of those agencies with respect to ICH guideline. Most of the stability requirements for WHO, ASEAN, and EMEA are similar to the ICH guideline, except for the parameters like selection of batches and storage conditions.
Highlights
Stability is defined as the capacity of a drug substance or drug product to remain within the established specifications which maintains its identity, strength, quality and purity throughout the retest or expiration dating period
The differences were observed in the parameters like selection of batches, storage conditions and statements and labeling. [5,11] 6.3 ASEAN guidelines: Association of South East Asian Nations (ASEAN) guideline mainly focuses on the requirements for stability testing of drug products along with new chemical entities (NCE’s)
This guideline addresses the information to be submitted an application for marketing authorization of drug products in ASEAN countries including examples of a protocol of stability study, a report format, reduced design and extrapolation of data, and examples of types, thickness and permeability coefficient which are covered in Annexes
Summary
Stability is defined as the capacity of a drug substance or drug product to remain within the established specifications which maintains its identity, strength, quality and purity throughout the retest or expiration dating period. The objective of stability study is to determine the shelf life, namely the time period of storage at a specified condition within which the drug product still meets its established specifications. Stability evaluation of drug substance or drug product is the key to drug quality as it determines the efficacy of any drug or dosage form. Stability testing provides evidence that the quality of drug substance or drug product changes with time under the influence of various environmental conditions such as temperature, relative humidity etc. The stability study consists of a series of tests in order to obtain an assurance of stability of a drug product, namely maintenance of the drug product packed in it specified packaging material and stored in the established storage condition within the determined time period. Types of stability study 2.1 Physical stability: Physical instabilities possibilities are like, 2.1.1 Crystal formation in pharmaceutical preparations: Causes of crystal formation in pharmaceutical formulations are like Polymorphism phenomena which are seen in Chloramphenicol, while in Saturated solution by different temperature precipitation of solute may occur and In suspension when very fine powder is used a part of suspending agent which dissolve and precipitated as crystals. 2.1.2 Loss of volatile substances: Loss of volatile substance from pharmaceutical dosage forms like Aromatic waters, Elixirs, Spirits and some types of tablets which contain aromatic water cases physical instabilities
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