Tag: Stability Guidance

How to Perform Stability Studies for Radiopharmaceuticals Stability Testing of Radiopharmaceuticals: A Comprehensive Guide Introduction Radiopharmaceuticals, which are used in both diagnostic imaging and therapy, require specialized stability testing due to their radioactive nature and the potential for rapid decay. Conducting stability studies for radiopharmaceuticals is crucial to ensure that these products maintain their efficacy,…

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How to Evaluate Stability in Cold Chain Products Stability Testing for Cold Chain Products: A Comprehensive Guide Introduction Cold chain products, such as vaccines, biologics, and certain pharmaceuticals, require strict temperature control during storage and transportation to maintain their stability, efficacy, and safety. Stability testing for cold chain products is critical to ensure that these…

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How to Conduct Stability Studies for Nasal Sprays Stability Testing of Nasal Sprays: A Comprehensive Guide Introduction Nasal sprays, which deliver drugs directly to the nasal cavity, require rigorous stability testing to ensure their efficacy, safety, and quality throughout their shelf life. Stability studies for nasal sprays are particularly important due to the potential impact…

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How to Perform Stability Studies in Line with ICH Guidelines Stability Testing According to ICH Guidelines: A Step-by-Step Guide Introduction The International Council for Harmonisation (ICH) has established globally recognized guidelines for the stability testing of pharmaceuticals. Conducting stability studies in line with ICH guidelines ensures that drug products meet the necessary quality standards for…

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How to Assess the Stability of Fixed-Dose Combinations Stability Testing of Fixed-Dose Combinations: A Comprehensive Guide Introduction Fixed-dose combinations (FDCs), which contain two or more active pharmaceutical ingredients (APIs) in a single dosage form, present unique challenges in stability testing due to potential interactions between the different components. Conducting stability studies for FDCs is crucial…

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How to Conduct Stability Studies for Transdermal Patches Stability Testing of Transdermal Patches: A Step-by-Step Guide Introduction Transdermal patches, which deliver drugs through the skin, require rigorous stability testing to ensure their efficacy, safety, and quality throughout their shelf life. The unique nature of transdermal patches, including their adhesive properties and the interaction between the…

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How to Perform Stability Studies for Dietary Supplements Stability Testing of Dietary Supplements: A Comprehensive Guide Introduction Dietary supplements, including vitamins, minerals, and herbal products, require stability testing to ensure that they maintain their potency, safety, and quality throughout their shelf life. The stability of dietary supplements can be influenced by various factors, including temperature,…

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How to Determine the Stability of Herbal Drug Products Stability Testing of Herbal Drug Products: A Comprehensive Guide Introduction Herbal drug products, derived from natural plant sources, present unique challenges in stability testing due to the complexity and variability of their constituents. Conducting stability studies for herbal drug products is essential for ensuring that these…

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