Residual Solvent Testing (GC)
Reliable, GMP-aligned analysis for APIs and finished products
Residual solvent testing identifies and quantifies trace organic solvents after manufacturing using validated GC-FID and GC-MS methods, ensuring compliance with ICH Q3C.
What is Residual Solvent Testing?
Residual solvent testing measures volatile organic solvents in drug substances, intermediates, excipients, or finished dosage forms. These solvents have no therapeutic effect and must remain within toxicologically acceptable limits.
Typical testing includes:
- Compendial and validated methods aligned with ICH Q3C and pharmacopoeial standards.
- Headspace GC analysis: GC-FID for routine quantification, GC-MS for confirmatory identification.
- Comprehensive matrix coverage, from APIs to finished products.
- Clear reporting against predefined acceptance criteria.
Why Residual Solvent Testing Matters
QbD Group combines scientific expertise with GMP-aligned execution and regulatory insight, delivering reliable, inspection-ready residual solvent testing across APIs and finished products with one trusted partner.
Patient Safety
Ensures solvent residues stay within safe, toxicologically acceptable limits to protect patients.
Regulatory Compliance
Supports filings and ongoing adherence to ICH Q3C and pharmacopoeial standards.
Reliable Batch Release
Provides robust, validated data for confident release decisions and quality assurance.
Operational Efficiency
Reduces the risk of late-stage issues during scale-up, tech transfer, or production changes.
Change Management Support
Confirms continued compliance after process, method, or site modifications.
How QbD Group Can Help
Our residual solvent testing services are tailored to your goals, whether for release, stability, investigations, or submission support. Our offerings include:
Routine Residual Solvent Testing (GC-FID)
Quantification of targeted residual solvents using validated headspace GC-FID workflows, ideal for high-volume, specification-driven testing.
Confirmatory Identification & Investigation (GC-MS)
GC-MS confirmation for unexpected peaks, non-target solvents, or atypical profiles, supporting scientifically informed decisions.
Compendial Method Execution & Verification
Execution and verification of compendial methods under a GMP-compliant framework to ensure suitability for your product matrix.
Stability & Lifecycle Testing Support
Monitoring residual solvents within stability programs and lifecycle activities, including scale-up, process optimization, or site transfer.
Flexible Reporting Options
Results delivered as a Certificate of Analysis or conformity-style report, with optional expanded formats for regulatory or toxicology submissions.
Our process
GMP-aligned execution from sample receipt to results delivery.
1. Consultation
Understanding your testing requirements and regulatory context.
2. Sample preparation
Processing samples using validated headspace GC methods.
3. Analysis & review
Running GC-FID/GC-MS with documented review steps.
4. Reporting
Delivering inspection-ready results with full traceability.
Why QbD Group
Your trusted partner
When partnering for residual solvent testing, clients benefit from:
GMP-aligned, inspection-ready data with controlled workflows and documented review steps.
Validated data systems supporting traceability, audit trails, and compliant record management.
Reliable GC testing without the need for internal investment in equipment or specialist resources.
Scalable capacity to meet peak testing demands during tech transfer, scale-up, and commercial launch.
Scientific support for atypical results, including GC-MS confirmation and clear guidance on next steps.
Let's talk Lab Services
From method validation to stability testing, our lab experts are ready to support your analytical needs.