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This document summarizes a seminar presentation on impurities and stability studies. It defines impurities as any component of a drug substance that is not the defined chemical entity. Impurities are classified as organic, inorganic, or residual solvents. Organic impurities can arise from manufacturing processes or storage and include starting materials, byproducts, and degradation products. Inorganic impurities result from manufacturing and include reagents, metals, and salts. Residual solvents are volatile organic chemicals used in drug substance synthesis. The document also discusses ICH guidelines for qualifying impurities based on safety testing and provides a decision tree for conducting safety studies of drug substances.
Presentation on impurities and stability studies in pharmaceuticals, led by Pradhuman Patel.
Outline of the seminar covering definitions, classifications, and qualifications of drug impurities.
Impurity defined as any component excluding the defined new drug substance or excipient.
Impurities classified into organic, inorganic, and residual solvents.
Organic impurities from drug manufacturing include starting materials, by-products, and degradation products.
Inorganic impurities typically identified include heavy metals, inorganic salts, and filter aids.
Definition of residual solvents as organic volatiles used in drug substance manufacturing.
Description of impurity qualification process as per ICH guidelines addressing safety evaluation.
Standards for reporting impurity levels quantitatively, with specific numerical accuracy guidelines.
A decision tree outlining safety studies relevant to drug substances.
Notes on exclusions from the safety study procedure for certain specific drug types and products.
References including internet resources and textbooks, and concluding thank you.












