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Residual Solvent Testing – USP <467> & ICH Q3C Compliant GC-FID / GC-MS Analysis
Comprehensive Residual Solvent Testing Services
USP <467> and ICH Q3C Compliant Testing with Headspace GC-FID and GC-MS
What Is Residual Solvent Testing?
Residual solvent testing is essential for identifying and quantifying volatile organic solvents that may remain in drug substances or products after manufacturing. These solvents can pose toxicological risks and must comply with regulatory limits defined in USP <467>, ICH Q3C, and other international guidelines. At ResolveMass Laboratories Inc., we use Headspace GC-FID and GC-MS for accurate, reliable, and compliant analysis of residual solvents in pharmaceuticals, chemicals, and personal care products.
Why Choose ResolveMass Laboratories Inc.?
✅ USP <467> & ICH Q3C (R8) Compliant Methods
✅ Dual Detection: GC-FID for Quantitation + GC-MS for Confirmation
✅ Fast Turnaround & High Sample Throughput
✅ FDA & cGMP-Aligned SOPs
✅ Raw Materials, APIs, Excipients, Finished Dosage Forms
✅ Expert Scientific Support & Regulatory Guidance
Our Analytical Capabilities in GC-FID and GC-MS
Headspace GC-FID Testing
- Ideal for known solvent quantification
- Complies with USP <467> Phase I–III
- Suitable for Class 1, 2, and 3 solvents
GC-MS for Unknown Solvent Identification
- Confirms identity of unknown peaks
- Used for method development, deviations, OOS
Optional Table: ICH Q3C Solvent Classes with Examples
| Class | Toxicity Level | Example Solvents |
|---|---|---|
| Class 1 | Avoid | Benzene, Carbon tetrachloride |
| Class 2 | Restricted | Methanol, Toluene, Acetonitrile |
| Class 3 | Low Risk | Ethanol, Acetone, Ethyl acetate |
Sample Types We Test
What Materials Do We Test?
| Material Type | Examples |
|---|---|
| APIs & Intermediates | Peptides, small molecules |
| Excipients | Solvents, carriers, surfactants |
| Drug Products | Tablets, injectables, topicals |
| Packaging Materials | Films, rubber stoppers, blisters |
| Nutraceuticals | Capsules, powders, tinctures |
Regulatory Compliance
Ensuring Compliance with Global Guidelines
Our residual solvent testing services fully align with:
- USP <467> Monograph
- ICH Q3C (R8) Guidelines
- FDA and EMA Requirements
- cGMP and GLP Data Integrity Standards
We deliver audit-ready documentation and CoAs to support your compliance submissions.
Deliverables You’ll Receive
✅ Certificate of Analysis (CoA)
✅ Chromatograms with labeled peaks
✅ PPM or µg/g quantification
✅ List of solvents detected by class
✅ Method summary (on request)
✅ Technical consultation support
Industries We Serve
Industries That Rely on Our Expertise
- Pharmaceutical Manufacturers
- Contract Manufacturing Organizations (CMOs & CDMOs)
- Biotech & Research Labs
- Personal Care & Cosmetics Companies
- Fine & Specialty Chemicals
Watch the webinar to learn more:
FAQ Section
Depends on the type of studies but for individual sample analysis, it usually takes 5–7 business days. Rush options available.
Yes, we offer tailored method development and validation.
The ICH Q3C guideline classifies residual solvents into three classes based on toxicity. Class 1 solvents like benzene should be avoided, Class 2 solvents are limited due to toxicity, and Class 3 solvents have low toxic potential. Limits range from as low as 2 ppm to 5000 ppm depending on the solvent and daily drug dose.
Need expert support for your FDA or Health Canada filing? ResolveMass Laboratories Inc. is here to help with expert-level Analytical Method Development in Montreal, Canada and United States (US). Contact our team today via our contact form, or call us directly for consultation. We typically respond within 24 hours.
Need expert support for your FDA or Health Canada filing? ResolveMass Laboratories Inc. is here to help with expert-level Analytical Method Development in Montreal, Canada and United States (US). Contact our team today via our contact form, or call us directly for consultation. We typically respond within 24 hours.
📍 Location: Montreal, Quebec, Canada
📧 Email: info@resolvemass.ca
🌐 Contact Page: https://resolvemass.ca/contact/