Elemental impurities testing

Our dedicated elemental impurities team is based at our state of the art cGMP facility in Cambridge (Fordham) 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 ppt levels as required for impurity quantification in high dose materials, as well as up to ppm or wt% levels where an assay is required.

From our site in Teddington, UK we offer speciation analysis for As, Hg and other elements to help investigate process chemistries and reaction studies.

LGC elemental impurity & inorganic testing

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Applications

• ICH Q3D and USP<232><233> elemental impurity screening
• Method development and validation
• Targeted metals analysis
• Extractable and leachable testing
• Pharmacopeia testing
• Active/Drug substance testing
• Finished product testing
• Raw materials testing
• QC, stability and batch release testing
• Metal speciation
• Contamination identification

Sample preparation

• Microwave digestion or extraction
• Wet chemical digestion
• Reflux extraction
• Fusion
• Solvent extraction

Techniques

• 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

We have in-depth technical knowledge and extensive experience in the quantitation of elemental impurities in pharmaceutical materials by ICP-OES/ICP-MS.

The wide variation in pharmaceutical material composition and the requirement for simultaneous multi-elemental determination across a wide concentration range can lead to significant analytical challenges. Our scientists are experienced in developing and validating both limit and quantitative test methodologies for a wide range of sample matrices, utilising a variety of specialised sample preparation techniques and digestion regimes.

We also have extensive expertise in the related field of metal speciation. We work with sponsors who have an issue in determining oxidation state (e.g. As III or As IV) such as in trace catalyst residues in pharmaceutical process streams or the presence of metals bound in an organic compound.