Elemental impurities testing
From our state of the art cGMP facility in Cambridge (Fordham), UK we offer targeted, bespoke screening and quantitative analysis of elemental impurities in final products, excipients, APIs, Raw Materials and packaging materials. We can perform reliable and accurate analysis in accordance with ICH Q3D and USP<232><233> guidelines by using a combination of ICP-MS and ICP-OES as appropriate.
This combination enables us to measure down to the low ppb or ppt levels required for impurity quantification in high dose materials up to ppm or wt% levels where an assay is required.
In addition, from our site in Teddington, UK we offer speciation analysis for As, Hg and other elements to ensure compliance and to help investigate process chemistries and reaction studies.
• ICH Q3D and USP<232><233> elemental impurity screening
• Method development and validation
• Targeted metals analysis
• Extractable and leachable testing (including Silicone oil)
• Monograph testing
• Active/Drug substance testing
• Finished product testing
• Raw materials testing
• Stability and release testing
• Metal speciation
• Contamination identification
• Microwave digestion or extraction
• Wet chemical digestion
• Reflux extraction
• Solvent extraction
• Inductively Coupled Plasma with Mass Spectrometry (ICP-MS) - Agilent 7700x and Agilent 7900
• Inductively Coupled Plasma with Optical Emission Spectrometry (ICP-OES) - Thermo iCAP7600 Duo