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Development
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Residual solvents, often found in pharmaceuticals, are volatile organic compounds that remain after processing. These solvents do not offer therapeutic benefits and must be managed to meet safety standards, including the WHO's Acceptable Daily Intake (ADI) and the Permitted Daily Exposure (PDE) measures. Solvents are classified into three categories based on toxicity, with Class 1 solvents being hazardous and to be avoided, Class 2 limited due to toxicity, and Class 3 considered low-risk. Compliance ensures product safety.

Fundamentals
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The content discusses the importance of maintaining drug quality through managing impurities and degradation products arising at various stages of drug synthesis, manufacturing, and storage. Impurities fall into categories such as organic, inorganic, residual solvents, elemental, and nitrosamines, each requiring specific thresholds for reporting, identification, and qualification. Comprehensive evaluation and justification based on safety and stability studies are crucial for establishing impurity acceptance criteria. The discussion also covers setting limits for specified and unspecified impurities in drug specifications according to regulatory guidelines.

Fundamentals
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Pharmaceutical products must maintain quality, safety, and efficacy throughout their lifecycle, influenced by environmental factors like temperature and humidity. Manufacturers must provide stability data, including stress testing and long-term studies, demonstrating product reliability and defining storage conditions. Comprehensive testing ensures regulatory compliance and builds confidence in product performance.

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