Tag: Stability Studies Guidelines

How to Assess the Stability of Drug Product Impurities Evaluating the Stability of Impurities in Pharmaceutical Products Introduction The stability of impurities in drug products is a critical aspect of pharmaceutical development, as impurities can impact the safety, efficacy, and overall quality of the drug. Impurities may form during manufacturing, storage, or even as a…

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How to Conduct Stability Studies for Intranasal Products Stability Testing Guidelines for Nasal Drug Delivery Systems Introduction Intranasal products, used for delivering drugs directly to the nasal cavity, require specialized stability testing to ensure their efficacy and safety. These products are sensitive to environmental factors such as temperature, humidity, and microbial contamination, making rigorous stability…

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How to Perform Stability Studies for Sustained Release Injections Stability Testing Guidelines for Extended-Release Injectable Formulations Introduction Sustained release injections, designed to release active pharmaceutical ingredients (APIs) over an extended period, require rigorous stability testing to ensure their efficacy and safety throughout their shelf life. These formulations are often complex, involving polymers or other matrices…

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How to Conduct Stability Studies for Protein Therapeutics Stability Testing Protocols for Protein-Based Drugs Introduction Protein therapeutics, including monoclonal antibodies, enzymes, and recombinant proteins, are highly sensitive to environmental factors such as temperature, pH, and light, which can lead to degradation or aggregation. Stability studies are critical for ensuring that these complex molecules maintain their…

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How to Evaluate Stability for Parenteral Emulsions Stability Testing Protocols for Injectable Emulsion Products Introduction Parenteral emulsions, used for intravenous administration of lipid-based drugs, require rigorous stability testing to ensure their safety and efficacy. These complex formulations are sensitive to environmental factors such as temperature, light, and mechanical stress, which can impact their stability and…

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How to Perform Stability Testing for Biological Drug Products Stability Testing Protocols for Biologics Introduction Biological drug products, including vaccines, monoclonal antibodies, and gene therapies, are derived from living organisms and require specialized stability testing to ensure their efficacy and safety over time. These products are highly sensitive to environmental factors such as temperature, light,…

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How to Conduct Stability Studies for Oncology Drugs Stability Testing Guidelines for Cancer Medications Introduction Oncology drugs, used to treat various forms of cancer, are often highly potent and require stringent stability testing to ensure their efficacy and safety over time. These drugs may include chemotherapeutic agents, targeted therapies, and immunotherapies, all of which are…

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How to Assess the Stability of Controlled Substances Stability Testing Protocols for Regulated Drugs Introduction Controlled substances, including opioids, stimulants, and certain sedatives, require rigorous stability testing to ensure their efficacy and safety over time. These substances are subject to strict regulatory controls, and their stability studies must comply with guidelines set by authorities such…

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