Tag: FDA Stability Testing Requirements

How to Perform Humidity Chamber Studies for Drug Products Conducting Humidity Chamber Studies for Drug Products: A Practical Guide Introduction Humidity is a key factor that can significantly affect the stability of drug products. Conducting humidity chamber studies allows pharmaceutical companies to assess how different levels of humidity impact the stability of a drug product…

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How to Conduct Photostability Testing of Drug Products Step-by-Step Guide to Photostability Testing of Drug Products Introduction Photostability testing is a vital component of the stability testing process, aimed at understanding how exposure to light affects the stability of drug products. Light exposure can lead to the degradation of active pharmaceutical ingredients (APIs), resulting in…

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How to Determine the Impact of Temperature on Drug Stability Evaluating Temperature’s Impact on Drug Stability: A Comprehensive Guide Introduction Temperature is one of the most critical factors affecting the stability of drug products. Understanding how temperature impacts a drug’s stability is essential for determining proper storage conditions and shelf life. Temperature fluctuations can accelerate…

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SOP for Conducting Stress Testing of Active Pharmaceutical Ingredients (APIs) Procedure for Stress Testing of Active Pharmaceutical Ingredients (APIs) 1) Purpose The purpose of this SOP is to provide a standardized procedure for conducting stress testing of Active Pharmaceutical Ingredients (APIs) to determine their intrinsic stability and to identify degradation products. This information is used…

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How to Establish Shelf Life Using Stability Data Determining Shelf Life with Stability Data: A Step-by-Step Guide Introduction Establishing the shelf life of drug products is a vital step in the pharmaceutical development process, ensuring that the products remain effective and safe for use over time. Shelf life is determined based on stability data, which…

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How to Perform Real-Time Stability Testing for Drug Substances Step-by-Step Guide to Real-Time Stability Testing of Drug Substances Introduction Real-time stability testing is a fundamental aspect of pharmaceutical development, providing the most accurate representation of a drug substance’s stability under normal storage conditions. This type of testing is essential for determining the shelf life and…

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How to Design a Stability Study Protocol for Drug Products Creating an Effective Stability Study Protocol for Drug Products Introduction Designing a stability study protocol is a critical step in ensuring the safety, efficacy, and quality of drug products throughout their shelf life. A well-designed protocol outlines the conditions and procedures for stability testing, providing…

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How to Conduct Accelerated Stability Testing of Pharmaceuticals A Comprehensive Guide to Accelerated Stability Testing of Pharmaceuticals Introduction Accelerated stability testing is a crucial aspect of the pharmaceutical development process, allowing manufacturers to estimate the shelf life of drug products in a relatively short period. This type of testing is important because it helps ensure…

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