Elemental Impurities Testing and Analysis

We deliver analytical impurities testing services essential for manufacturing compliance and product quality:

• Elemental impurity testing
• Implementation of ICH Q3D elemental impurities guideline
• USP <232>/<233> implementation of elemental impurity screening
• Method development and validation
• Limit test validation
• Quantitative method validation
• Semi-quantitative screening
• Trace metal analysis
• Targeted metals analysis
• Monograph (compendial) testing
• Extractables and leachables studies
• API and drug substance testing
• Raw materials testing
• Finished product testing
• Stability studies
• Batch and lot release testing
• Metal speciation
• Impurity characterization  

Comprehensive testing capabilities cover your entire production chain, from raw materials through finished products. Our analysis includes APIs, drug substances, excipients, packaging materials, and container closure systems to identify potential sources of elemental impurities. We evaluate all materials that could introduce impurities, including those intentionally added during synthesis (such as catalysts),  those potentially present in materials used to prepare drug products, and any elements that may be introduced from manufacturing equipment or container closure systems.

Our advanced sample preparation techniques include closed-vessel microwave digestion, acid digestion, base digestion, solvent extraction, and reflux extraction. These methods achieve superior detection limits - sub-ppb for elements like calcium and sodium, and sub-ppt for select applications. Our scientists develop and validate customized methods for challenging APIs and complex matrices, particularly those with poor solubility.

Elemental impurities sample preparation techniques:

• Closed-vessel microwave digestion
• Open-vessel microwave digestion
• Wet chemical digestion
• Acid digestion
• Base digestion
• Solvent extraction
• Reflux extraction

State-of-the-art ICP-MS technology coupled with three collision gases enables detection of elements typically obscured by polyatomic interferences, such as sulfur and silicon. Our advanced microwave digestion systems handle challenging matrices including plastics, lubricants, and complex pharmaceutical formulations. This specialized equipment allows for detection limits in the sub-parts per billion range for elements such as calcium, sodium, potassium, and silicon.

Our team operates from Life Sciences hubs across the world, providing global access to our expert capabilities. Find your nearest Life Sciences hub on our Locations Page.

Our consultative team provides strategic guidance throughout drug development, helping establish effective controls and monitoring programs that align with regulatory requirements. We support your elemental impurities risk assessment with recommendations for control strategies that meet USP <232>/<233> and ICH Q3D standards, while optimizing your manufacturing processes.