IMPURITIES AND STABILITY STUDIES

Presentation on impurities and stability studies in pharmaceuticals, led by Pradhuman Patel.View

Outline of the seminar covering definitions, classifications, and qualifications of drug impurities.View

Impurity defined as any component excluding the defined new drug substance or excipient.View

Impurities classified into organic, inorganic, and residual solvents.View

Organic impurities from drug manufacturing include starting materials, by-products, and degradation products.View

Inorganic impurities typically identified include heavy metals, inorganic salts, and filter aids.View

Definition of residual solvents as organic volatiles used in drug substance manufacturing.View

Description of impurity qualification process as per ICH guidelines addressing safety evaluation.View

Standards for reporting impurity levels quantitatively, with specific numerical accuracy guidelines.View

A decision tree outlining safety studies relevant to drug substances.View

Notes on exclusions from the safety study procedure for certain specific drug types and products.View

References including internet resources and textbooks, and concluding thank you.View