Our Elemental Impurity Studies ensure that your pharmaceutical products meet the stringent regulatory requirements set by the ICH Q3D guidelines, ensuring safety and compliance for drug substances and products.

We provide comprehensive testing for elemental impurities, including:

• Heavy metals (e.g., arsenic, cadmium, lead, mercury)
• Trace elements (e.g., iron, zinc, copper, nickel)
• Method development and validation for sensitive detection
• Risk assessment and identification of potential sources
• Compliant testing for APIs, excipients, and final products

Using highly sensitive techniques such as Inductively Coupled Plasma Mass Spectrometry (ICP-MS) and Atomic Absorption Spectroscopy (AAS), we ensure the accurate and reliable detection of trace elemental impurities. Our services help you meet global regulatory standards, supporting your product safety and market approval.