Tag: light-induced degradation

Design Photostability Studies with Cool White Fluorescent Lamps

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Understanding the Tip: Why photostability testing is essential: Pharmaceutical products exposed to light may undergo degradation, leading to reduced potency, discoloration, impurity formation, or complete therapeutic failure. Photostability testing evaluates a product’s resilience to light and determines the need for protective packaging or labeling. It is a regulatory requirement for all new drug substances and…

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Stability Study Tips

Don’t Assume Photostability—Test Even Foil or Opaque Packaging

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Understanding the Tip: Why testing photostability is essential regardless of packaging appearance: Many stability programs bypass photostability testing if the product is stored in foil or opaque packaging. However, visual appearance is not a scientific measure of light protection. Even foil or opaque materials may allow trace light transmission, degrade over time, or show microdefects…

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Stability Study Tips

Store Photostability Samples in Transparent and Protective Packaging

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Understanding the Tip: Purpose of dual packaging in photostability testing: Photostability testing involves exposing pharmaceutical products to light to evaluate their stability under light stress conditions. ICH Q1B recommends storing samples in both light-transmitting (transparent) and light-protective (e.g., foil-wrapped or amber) containers during testing to differentiate between light-induced and non-light-induced changes. This setup ensures that…

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Stability Study Tips