hrvatski

Metalna onečišćenja u kontroli kakvoće lijekova

Metal impurities in pharmaceuticals originate from different sources, i.e. through raw materials, catalyst, reagents, solvents, various equipments used in the synthesis, etc. They have the potential to affect safety and efficacy of medicines. Current control of inorganic impurities has been primarily based on pharmacopoeial requirements for heavy metals with questionable capabilities of pharmacopoeial methods for detecting and quantification of some toxicologically significant metals. In the past few years, the subject of metals analyses in pharmaceuticals has gained considerable interest. With a focus on patient safety, the process of international harmonization of guidelines (ICH Q3D) has been initiated as well as the revision of relevant chapters in the United States Pharmacopoeia (USP) and European Pharmacopoeia (Ph. Eur.). Apart from defining the metals to be monitored and stringent limits, the use of instrumental techniques in routine analysis is being proposed. This work gives a detailed overview of the proposed changes and shortcomings of traditional approaches in pharmacopoeial limit test for metals, the literature survey of the risk-based approach in establishing an effective control system for metal impurities in pharmaceuticals and the benefits of the use of ICP-MS technique in complying with the more stringent requirements.

Metalna onečišćenja ; lijekovi ; ICP-MS

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