Elemental Impurities Emerge As New Compliance Challenge

March 13th, 2019 by Adam C. Fox

By Adam C. Fox, Senior Vice President, Analytical Operations, Nitto Avecia Pharma Services

Scientist holding a red capsule in blue-gloved fingers

Why is this service needed?

After almost 20 years of discussion, the FDA issued new guidelines in 2018 for controlling and measuring the risk of contamination within pharmaceutical products due to the presence of heavy metals.

The agency issued guidance in August 2018 regarding the control of elemental impurities of human drug products. The guidance is consistent with implementation of International Council for Harmonisation (ICH) guidance for industry Q3D Elemental Impurities (ICH Q3D), the FDA says.

At a minimum, drug manufacturers must consider common heavy metals such as arsenic, cadmium, lead, and mercury in risk assessments, the FDA said when announcing the standards.

What is the Nitto Avecia Pharma Services solution?

The company offers services to develop/transfer, validate, and test elements listed in U.S. Pharmacopeia (USP) <232> and beyond. And, it performs general screening for elements listed in USP <232> and beyond (for informational purposes only).

How is Nitto Avecia Pharma Services different?

With nearly 30 years of analytical experience with heavy metals, Nitto Avecia Pharma Services offers trace-level impurity analysis that meets both USP and ICH standards and far exceeds services offered by most competitors. For instance, few providers can match the Nitto Avecia Pharma Services full-panel screening option that examines 32 elemental impurities.

The company also tests elemental impurities with greater specificity and reliability than other contract development and manufacturing organizations. Using inductively coupled plasma (ICP) technology, Nitto Avecia Pharma Services detects elemental impurities down to the parts-per-trillion level. Having invested in system redundancy to ensure client studies stay on track, Nitto Avecia Pharma Services possesses the technology dedicated to elemental impurities. This includes ICP systems coupled with atomic emissions spectroscopy and ICP coupled with mass spectrometry.

Nitto Avecia Pharma Services takes on the tough jobs that other suppliers decline. Creams, gels, and ointments present drug manufacturers with sticky analytical issues. Most competitors struggle to handle elemental impurities analysis of these vehicle types. Nitto Avecia Pharma Services welcomes the challenge. The company has a long history of experience with these products, delivering successful protocols with hydrofluoric (HF) acid digestion and microwave digestion. It has the right personnel, expertise, and quality management system to conduct the studies quickly and efficiently.

Why work with Nitto Avecia Pharma Services?

The 2018 elemental impurities standards are just the start of new compliance directives for drug manufacturers. But Nitto Avecia Pharma Services has been preparing for decades by actively participating in this arena since the early 2000s with technical posters, papers, and presentations, and through collaboration with clients. Partnering with an experienced provider will help you manage the risk of elemental impurities as more standards appear in coming years.

Posted in: BioProcess Online, Outsourced Pharma

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