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Stability-indicating assay method
21 Feb 2024

What is a Stability-indicating assay method?

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A stability-indicating assay method is a type of analytical technique used in pharmaceutical analysis to determine the stability of a drug substance or drug product over time. The primary goal of such a method is to accurately quantify the active pharmaceutical ingredient (API) in the presence of its degradation products and other impurities that may form during storage or upon exposure to various environmental factors such as light, heat, moisture, or pH.

Generally forced degradation/stress testing is used to generate the samples for stability-indicating assay methods. Forced degradation/stress testing is defined as “the stability testing of drug substance and drug product under conditions exceeding those used for accelerated stability testing”.

Definition

A Stability-indicating assay method can be defined as “Validated quantitative analytical method that can detect the change with time in the chemical, physical or microbiological properties of the drug substance and drug products are specific so that the content of active ingredients and degradation products can be accurately measured without interference”.

Methods

  • These methods are essential in pharmaceutical development and quality control to ensure that the drug product maintains its potency, safety, and efficacy throughout its shelf life. A stability-indicating assay method must be able to separate, identify, and quantify the drug substance from any degradation products or impurities that may arise during storage or under stress conditions.
  • Common techniques used in stability-indicating assays include high-performance liquid chromatography (HPLC), gas chromatography (GC), capillary electrophoresis (CE), and spectroscopic methods such as UV-Vis spectrophotometry or mass spectrometry (MS). These methods are often coupled with various detectors to enhance specificity and sensitivity in detecting and quantifying impurities.
  • Overall, stability-indicating assay methods play a crucial role in ensuring the quality, safety, and efficacy of pharmaceutical products throughout their lifecycle.

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