Heavy metal contamination in pharmaceuticals is subject to secific regulations and hast to be controlled and monitored in order to protect customers against possible side effects. Authorities are responsible for the permanent gurantee of stabaility and safety of pharmaceuticals. There are regional differences regarding requirements and limit values, that have to be complied with. Though, potential toxic contamination caused by heavy metals have to be identified and limit values have to be complied with in every case.
Modern methods allow an elemental selective and quantitative analysis. The regulations of chapters <232> and <233> of US Pharmacopoeia, that have been valid since January 2018, define limit values as well as modern procedures for determination of potential contamination. By publishing chapters 5.20 and 2.4.20, the European Pharmacopoeia (Ph. Eur.) has defined new regulations, as well. The regulations of USP and Ph. Eur. show some differences regarding the elements prescribed and the limit values dafined. Therefore, the goal of the ICH Q3D regulation is to harmonize approval requirements of various norms and to define limit values of different dosage forms...
The whole article can be found in LABO magazine (edition 9/2019), on www.labo.de or as pdf-file below. Pleas note: the whole article is only available in German language.
Download article (German)
Microwave Digestion for Pharma Analysis
Used Berghof Instrument
Максимальная многовариантность при разложении проб при температурах до 260° C и давлении до 100 bar.