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E&L Study: ICH Stability Storage

Gateway Analytical offers a comprehensive approach to ICH stability storage, providing a critical assessment of drug products under various environmental conditions. This process adheres to the guidelines set by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), focusing on vital stability testing.

Gateway Analytical - Analysis Solutions

E&L Study: ICH Stability Storage

ICH stability storage is a process used in the pharmaceutical industry to evaluate the stability of a drug product under various conditions. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) provides guidelines for the stability testing of pharmaceutical products.

Gateway Analytical - Analysis Solutions

E&L Study: ICH Stability Storage

These guidelines include recommendations on the types of tests to be performed, the length of time for testing, and the storage conditions for the product. Stability testing is important to ensure the drug product remains safe and effective throughout its shelf life and when stored under different environmental conditions. The stability testing results are used to determine the product’s expiration date.

-25C°
Storing pharmaceutical products at 25 degrees Celsius is a recommended condition for ICH stability testing. This temperature is considered to be a moderate level of stress on the drug product. It can help determine the shelf life and effectiveness of the product under normal storage conditions. By conducting stability testing at 25 degrees Celsius, pharmaceutical companies can ensure that their products remain safe and effective throughout their shelf life.
-40C°
Storing pharmaceutical products at 40 degrees Celsius is another recommended condition for ICH stability testing. This temperature is considered a high-stress level on the drug product and can help determine the shelf life and effectiveness under accelerated storage conditions. By conducting stability testing at 40 degrees Celsius, pharmaceutical companies can predict their products' shelf life and efficacy under extreme conditions and make informed decisions about labeling and storage recommendations.
-60C°
Storing pharmaceutical products at 60 degrees Celsius is also a common condition for ICH stability testing. This temperature is considered to be even more extreme and stressful on the drug product compared to the 40 degrees Celsius condition. Stability testing at 60 degrees Celsius can help pharmaceutical companies determine their products' shelf life and efficacy in harsh conditions. This information can be valuable in making informed decisions about labeling, storage recommendations, and potential concerns with the distribution and transportation of the products.
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Gateway Analytical offers a comprehensive approach to ICH stability storage, providing a critical assessment of drug products under various environmental conditions. This process adheres to the guidelines set by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), focusing on vital stability testing.

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Quantitative, non-destructive, deterministic leak detection technologies for products stored in vials, syringes, cartridges, flexible containers, and bottles.

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Multi-analytical methods to count, size, and characterize visible and subvisible particulate matter in pharmaceuticals, disposable containers, single-use systems, raw materials, and medical devices.

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Rigorous studies focused on enumerating particulate matter and identifying potential chemical compounds that could migrate from medical devices into the environment or directly impact patient health.

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