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Effects of Residual Carbon Content Matrix on Determining Pharma Regulated Elemental Impurities

RCC matrix effects on regulated elements were assessed in this study.

Released By Almac Group

In recent years, several changes to elemental impurities control strategy in active pharmaceutical ingredients (APIs), drug  products (DPs) and excipients were proposed by the United States Pharmacopoeia (USP), European Pharmacopoeia/European Medicine Agency (EP/EMA) and the International Conference on Harmonisation (ICH). The wet chemistry colorimetric tests for heavy metals such as USP and EP 2.4.8 have been replaced with instrumental methods, one of which being inductively coupled plasma mass spectrometry (ICP-MS) that provides fast, specific and quantitative determination of individual elemental impurities. ICP-MS has the capability to quantify the 24 regulated elemental impurities using a single method, whether present at ultra-trace levels or high concentrations, due to the instruments’ wide dynamic range (up to 11 orders).

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