Elemental impurities contained in pharmaceutical products are getting more and more attention due to their harmful potential on patient health and impact on drug shelf life and efficacy. ICP-MS is an ...

Common approaches to analyze elemental impurities for compliance with regulatory requirements are robust but still have some limitations. Elemental impurities present in a drug product are associated ...

Elemental impurities in pharmaceutical products represent a critical area of research, driven by heightened regulatory scrutiny and a growing imperative to ensure patient safety. Such impurities, ...

When evaluating a drug’s risk assessment for elemental impurities, one must consider all aspects of its lifecycle. The safety of a drug product is as important as its effectiveness. Testing a drug for ...

Before all verification work begins, the element impurities that need to be tested must first be clarified. For different routes of administration, the regulations stipulate the corresponding elements ...

Inductively coupled plasma mass spectrometry (ICP-MS) is prominently used for analyzing elemental composition in individual cells. However, the conventional sample introduction system of ICP-MS causes ...

Earlier this month, the US-based contract service provider CD Formulation announced that its management has decided to further optimize its elemental impurities analysis services. Previously, the ...

Inductively coupled plasma (ICP) analysis is among the most commonly used tools, yet it is not always the best method. This is because sample digestion and frequent calibration are necessary ...