Current Requirements for Assessment of Elemental Impurities (Heavy Metals) in Medicines

详细

One element of ensuring the quality and safety of medicines consists of normalizing and controlling elemental impurities (heavy metals). The sources and causes of the presence of elemental impurities (heavy metals) in medicines are discussed. Changes in approaches to assessment of elemental impurities in medicines in the State Pharmacopeia and leading non-Russian pharmacopeias are discussed. A risk-oriented approach to assessing elemental impurities used in international practice is presented.