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Routine Residual Solvent Testing (GC-FID)
Quantification of targeted residual solvents using validated headspace GC-FID workflows, ideal for high-volume, specification-driven testing.
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, we ensure compliance with ICH Q3C and pharmacopoeial standards, providing inspection-ready data that protects product quality and patient safety.
Applications include: routine release testing, stability programs, and support for scale-up, process updates, and method or site transfers.
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 and specifications
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Why QbD Group?
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
Full lifecycle support
Scalable expertise
Global team of 600+ experts
20+ years of experience
Get in touch
Partner with QbD Group to ensure your APIs and finished products meet regulatory standards and quality expectations. Fill out the form, and our experts will help you design a compliant residual solvent testing plan, interpret results with confidence, and support your release, stability, or submission needs.
