Impurities in Pharmaceuticals

 

Impurities in Pharmaceuticals

Impurities in Pharmaceuticals

Impurities

—  A drug product or any entity that is not a component of formulation ingredient.

—  In pharmaceuticals impurities are the unwanted chemical entities that remain with active ingredients, develop during formulation or with aging of active pharmaceutical ingredients or formulated product.

Classification

—  Organic Impurities

—  In organic impurities

—  Residual solvents

—  Organic Impurities

—  Identified or unidentified impurities that forms during manufacturing process or during storage of new drug substance.

—  They include the following

—  Starting materials

—  By-products

—  Intermediates

—  Degradation products

—  Reagents, ligands and catalysts

—  In organic impurities

—  Inorganic  impurities are mostly identified and arise during manufacturing process.

—  They include

—  Reagents

—  ligands and catalysts

—  Heavy metals or other residual metals

—  Inorganic salts

—  Other materials (e.g., filter aids, charcoal)

—  Residual solvents

—  Residual solvents are organic or inorganic liquids of known toxicity that are used as vehicle for solution or suspension preparations of new drug substance.