Elemental Impurities Analysis
Bespoke Elemental Impurities Analysis services to support you at every stage of product development and manufacture.
Resolian’s Elemental Analysis team is committed to providing you with the most reliable and comprehensive elemental impurities testing services.
As your partner, Resolian can help ensure the safety and compliance of your products, no matter the complexity of your analytical challenges.
Our dedicated elemental impurities team offer targeted, bespoke screening and quantitative analysis of elemental impurities in final products, excipients, APIs, raw materials and packaging materials.
We perform reliable and accurate analysis in accordance with ICH Q3D and USP <232><233> guidelines 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. Our team also has extensive experience in the preparation of samples in complex matrices including the unique challenges of topical products.
We deliver these cGMP compliant services from our purpose built, dedicated elemental analysis laboratory to minimise contamination, achieve low backgrounds and increase sensitivity.
Reach out to us directly to learn more about Resolian’s Elemental Impurities Analysis services.
Applications
- ICH Q3D and USP <232><233> elemental impurity screening
- Method development and validation
- Targeted metals analysis
- Extractable and leachables testing
- Pharmacopeia testing
- Active/Drug substance testing
- Finished product testing
- Raw materials testing
- QC, stability and batch release testing
- Metal speciation
- Contamination identification
- Microwave digestion or extraction
- Wet chemical digestion
- HF capability
- Solvent extraction
Sample Preparation
Techniques
- Inductively Coupled Plasma with Mass Spectrometry (ICP-MS) – Agilent 8900-QQQ 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 requirement for simultaneous multi-element determination, often in complex matrices, across a wide concentration range can lead to significant analytical challenges.
Our scientists are experienced in the development and validation of both limit and quantitative test methods for a wide range of sample matrices.
Services in Detail
Tailored Elemental Impurities Testing:
Offering customized limit test based screening methods for your specific sample matrix, dosage route, and daily dose combination.
Versatile Method Development:
Developing and validating both quantitative and limit test methods, even for challenging scenarios like high-dose parenterals and complex topical products.
Microwave Digestion and Extraction:
Utilizing microwave technology to efficiently digest and extract elements from various sample types.
HF Acid Total Digestion:
For comprehensive elemental analysis, Resolian employs HF acid total digestion to ensure no element goes unnoticed.
Simulated Use Extraction:
Simulating real-world conditions to assess the potential release of elemental impurities under practical usage scenarios.
Extractable & Leachable Testing:
Resolian’s expertise extends to Extractables & Leachables testing to evaluate the impact of container-closure and single-use systems on your product.
