Development of validated stability-indicating assay methods--critical review.

Development of forced degradation and stability indicating studies of drugs-A review.

Q2(R1) Validation of Analytical Procedures

Stability studies ensuring the maintenance of product quality, safety and efficacy throughout the shelf life are considered as pre-requisite for the acceptance and approval of any pharmaceutical product These studies are required to be conducted in a planned way following the guidelines issued by ICH, WHO and or other agencies Importance of various methods followed for stability testing of pharmaceutical products, guidelines issued for stability testing and other aspects related to stability of pharmaceutical products have been presented in a concise manner in the present review

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Stability Testing of Pharmaceutical Products

Rapid quantification of malondialdehyde in plasma by high performance liquid chromatography-visible detection.

he International Conference on Harmonization (ICH) guideline entitled ‘Stability Testing of New Drug Substances and Products’ (Q1A) requires that stress testing be carried out to elucidate the inherent stability characteristics of the active substance (1). It suggests that the degradation products that are formed under a variety of conditions should be identified and degradation pathways established. It is stated that the testing should include the effect of temperature, humidity where appropriate; oxidation, photolysis and susceptibility to hydrolysis across a wide range of pH values. In the guideline, the study of the effect of temperature is suggested to be done in 10 C increments above the accelerated temperature test condition (e.g. 50 C, 60 C, etc.) and that of the humidity at a level of 75 percent or greater. No details are, however, provided for the study of oxidation, photolysis and hydrolysis at different pH values. In the absence of guidance, difficulties are faced by practitioners to decide on the stress conditions to be employed for a new drug at the time of initiation of forced decomposition studies. In this write-up the authors propose a classification system for categorization of drugs based on their inherent stability behaviour. Flow charts have been drawn that are suggested to be followed for determining the stress test conditions for hydrolysis (under neutral, acid and alkaline conditions), oxidation, and photolysis.

Monika Bakshi

Papers

Development of validated stability-indicating assay methods--critical review.

Guidance on Conduct of Stress Tests to Determine Inherent Stability of Drugs

Quantitative structure-property relationships in pharmaceutical research - Part 1.

The ICH guidance in practice: stress degradation studies on ornidazole and development of a validated stability-indicating assay

Quantitative structure-property relationships in pharmaceutical research - Part 2.