Compendia methods have historically been used to assess heavy metals in both drug
products and packaging material extracts. However, these methods have been found to be …

Elemental impurities in drug products arise from different sources and via a number of
different means, including leaching of elemental entities (including the elements themselves …

Elemental impurities in drug products can arise from a number of different sources and via a
number of different means, including the active pharmaceutical ingredient, excipients, the …

To support the practical implementation of the International Council for Harmonisation (ICH)
Q3D guideline, which describes a risk-based approach to the control of elemental impurities …

Recent regulations on heavy metal testing have required the pharmaceutical industry to
monitor a suite of elemental impurities in pharmaceutical raw materials, drug products and …

Control of elemental impurities in pharmaceutical materials is currently undergoing a
transition from control based on concentrations in components of drug products to control …

Nearly 100 individual test articles, representative of materials used in pharmaceutical
applications such as packaging and devices, were extracted under exaggerated conditions …

The safety aspects of elemental impurities in finished drug products are a topic of
considerable importance in the pharmaceutical community, and guidelines such as ICH …

Container closure systems that are used for packaging pharmaceutical products are
required to satisfy numerous safety requirements. Maximum permitted limits on the …

New guidelines relating to elemental impurities from the International Conference on
Harmonization (ICH), Q3D Guideline for Elemental Impurities (1) have presented the …