Elemental Impurities
Quercus Laboratories – a member of the QbD Group – is a trusted GMP Laboratory that supports the pharmaceutical industry with a wide range of QC testing services, including elemental analyses.
We offer a complete service from chemical and microbiological QC testing of raw materials and finished drug products. Please do not hesitate to contact us for more information on Elemental Impurities services.
Implementation of ICH Q3
Elemental Impurities guidelines
ICH Q3 described expectations regarding the control of elemental impurities in medicinal products or their excipients. Recently, authorities have been increasingly focusing on elemental impurities.
A control strategy should be implemented if the risk assessment shows that a source of elemental impurities exceeds 30% of the PDE limit for that drug. As part of a risk assessment or control strategy, you may need to conduct testing for elemental impurities.
According to ICH Q3D guidelines, procedures from the pharmacopoeia should be used, or suitable alternative procedures. Typically, analyses will be performed using inductively coupled plasma mass spectrometry ICP-MS, as it allows low detection limits.
Quercus can support you with ICP-MS analyses for elemental impurities and heavy metals, but our experts can also advise on best practices to meet the requirements of ICH Q3.
Using an accredited contract laboratory is often a very effective way to perform validations and routine elemental analyses. Benefits include
- speed of analysis
- knowledge
- clear visibility of costs upfront