Problems Connected with the Analytical Investigation of Drug Substances Analytik und Problematik bei der Untersuchung von Arzneistoffen

Abstract

Many substances are described as monographs in Pharmacopoeias (Pharm.Eur, USP, Pharm Jap., Pharm. Int.). The most important step during the elaboration of a monograph represents the choice of the analytical procedure (method) for identification, purity testing and the assay of a drug substance. Special attention must be paid to impurities that are known to possess or are suspected to have toxic properties.

Keywords

• Analytic
• Drug substances
• Impurities
• Pharmacopoeia