Tag: Stability Protocols for New Drugs

How to Evaluate the Impact of Light Exposure on Drug Products Assessing the Impact of Light Exposure on Drug Products: A Comprehensive Guide Introduction Light exposure can significantly affect the stability of drug products, leading to degradation of active pharmaceutical ingredients (APIs) and impacting the efficacy and safety of the product. Understanding how light influences…

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How to Perform Stability Studies for Novel Drug Delivery Systems Stability Studies for Novel Drug Delivery Systems: A Step-by-Step Guide Introduction Novel drug delivery systems, such as nanoparticles, liposomes, and targeted delivery platforms, present unique challenges in stability testing due to their complex and innovative nature. Conducting stability studies for these advanced delivery systems is…

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How to Conduct In-Use Stability Testing A Comprehensive Guide to In-Use Stability Testing of Drug Products Introduction In-use stability testing is essential for assessing how drug products maintain their stability, safety, and efficacy after being opened or reconstituted for use. This type of testing is crucial for products that are intended to be used over…

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How to Determine the Shelf Life of Parenteral Products Determining Shelf Life for Parenteral Products: A Step-by-Step Guide Introduction Parenteral products, which are administered via injection, infusion, or implantation, require rigorous stability testing to ensure their safety, efficacy, and quality over time. Determining the shelf life of parenteral products is essential for setting appropriate expiration…

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How to Perform Long-Term Stability Testing A Comprehensive Guide to Performing Long-Term Stability Testing Introduction Long-term stability testing is a critical component of pharmaceutical development, providing essential data on how drug products behave under normal storage conditions over extended periods. This type of testing is crucial for determining the shelf life of a product and…

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How to Assess the Effect of pH on Drug Stability Evaluating the Impact of pH on Drug Stability: A Step-by-Step Guide Introduction The pH of a drug product can significantly impact its stability, affecting both the chemical integrity of the active pharmaceutical ingredient (API) and the overall formulation. Understanding how pH influences drug stability is…

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How to Conduct Stability Testing for Solid Oral Dosage Forms A Step-by-Step Guide to Stability Testing for Solid Oral Dosage Forms Introduction Solid oral dosage forms, such as tablets and capsules, are among the most common forms of drug products. Conducting stability testing for solid oral dosage forms is essential to ensure that these products…

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How to Evaluate Stability of Combination Products Evaluating the Stability of Combination Products: A Step-by-Step Guide Introduction Combination products, which include two or more regulated components (e.g., drug-device, biologic-device), present unique challenges in stability testing due to the interaction between the different components. Evaluating the stability of combination products is essential to ensure that the…

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