Residual Solvent & Monomer Analysis
Residual solvent and monomer analysis identifies and quantifies volatile and semi-volatile chemical species that remain following synthesis, polymerization, curing, or manufacturing processes. Even at trace levels, these residuals can directly influence biocompatibility, mechanical performance, odor, toxicity, shelf life, and overall regulatory acceptance of a material or finished product.
At Materials Metric, residual solvent and monomer analysis is performed using advanced chromatographic and spectrometric techniques—including GC–MS, HPLC, FTIR, and targeted mass spectral identification—to generate precise chemical fingerprints of remaining solvents, unreacted monomers, oligomers, and processing by-products. Our testing supports material qualification, product release, stability assessment, and compliance with ISO, FDA, ICH Q3C, and international regulatory requirements.
Uses of Residual Solvent & Monomer Analysis
Residual solvent and monomer testing is used to:
- Detect and quantify volatile and semi-volatile impurities
- Confirm polymerization, curing, and crosslinking completion
- Evaluate manufacturing consistency and process control
- Support ICH Q3C residual solvent compliance
- Assess off-gassing, odor, toxicity, and safety risks
- Verify suitability of materials for medical, pharmaceutical, and food/consumer applications
- Troubleshoot incomplete reactions, catalyst issues, or contamination
Applications
Residual solvent and monomer analysis is essential for:
- Medical device polymers, elastomers & biomaterials
- Hydrogels, coatings, adhesives & sealants
- Pharmaceuticals, intermediates & raw materials
- Packaging (pharma, food-contact, consumer)
- Composite materials & chemical feedstocks
- 3D-printed / additively manufactured materials
- Industrial and specialty polymers
Sample Analysis Process
1. Objective Review & Method Selection
- Identify target solvents/monomers
- Determine regulatory requirements (ICH Q3C, ISO, USP, FDA)
- Select appropriate methodGC–MS, HPLC, or FTIR
2. Sample Preparation
- Controlled thermal or solvent extraction when needed
- Headspace conditions optimized for volatile profiling
- Solvent extraction or dissolution for monomer detection
3. Analytical Measurement
- GC–MS for sensitive detection of residual solvents
- HS-GC for volatile organic compound profiling
- HPLC for monomer/oligomer quantification
- FTIR screening for functional groups when applicable
4. Reporting
- Quantitative concentrations (ppm, mg/kg, μg/g)
- Identification of unknown peaks (if requested)
- Interpretation for safety, stability, and regulatory relevance
- Recommendations for process optimization or contaminant mitigation
Why Choose Materials Metric for Residual Solvent & Monomer Analysis
Materials Metric provides regulatory-ready, high-precision chemical profiling designed for industries where safety, purity, and process control cannot be compromised.
We deliver capabilities that many standard labs cannot match:
• High-Sensitivity GC–MS & Headspace GC for True Trace Detection
We quantify volatile and semi-volatile compounds at exceptionally low detection limits, ideal for medical devices, pharmaceuticals, and biomaterials.
• Expertise in Polymer, Biomaterial & Industrial Chemistry
Our scientists understand polymerization mechanisms, monomer reactivity, curing chemistry, and degradation pathways, allowing us to interpret the chemistry behind your results, not just report numbers.
• Full Regulatory Alignment (ICH Q3C, ISO, USP, FDA)
Our reports meet the expectations required for audits, submissions, and high-risk applications.
• Advanced Multi-Technique Verification
We integrate GC–MS, HPLC, FTIR, and thermal analysis when needed to confirm results and detect hidden impurities.
• Actionable Insights, Not Just Data
We provide clear guidance on:
- whether impurities exceed regulatory limits
- whether polymerization or curing is incomplete
- whether stabilizer formulations need adjustment
- whether process changes are required
Materials Metric delivers defensible, audit-ready chemical data with the scientific interpretation required for decision-making in high-consequence environments.