Residual solvent testing in United States is an important quality control process required to meet both USP <467> and FDA guidelines for pharmaceuticals and active pharmaceutical ingredients (APIs). At ResolveMass Laboratories Inc., we help pharmaceutical manufacturers, contract research organizations (CROs), and formulators follow the rules through validated, advanced testing methods that detect even trace levels of volatile organic compounds (VOCs).
Why Residual Solvent Testing in United States is Non-Negotiable
Residual solvents are organic volatile chemicals used during manufacturing or formulation but are not completely removed by the final processing steps. If not carefully checked, they can cause serious health problems. That’s why residual solvent testing in United States is not just a regulatory requirement but also a key part of product safety and quality assurance.
FDA and United States Pharmacopeia (USP) require regular testing and classification of residual solvents to protect patients from exposure to carcinogens, neurotoxins, and other harmful compounds. The standard to follow in the U.S. is USP <467>, supported by FDA’s guidance on impurities.
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🔗 Residual Solvent Testing Services – ResolveMass
USP <467>: The Core Standard for Residual Solvent Testing in United States
USP <467> classifies solvents into three categories:
- Class 1: Solvents to be avoided (e.g., benzene, carbon tetrachloride)
- Class 2: Solvents to be limited (e.g., methanol, acetonitrile)
- Class 3: Solvents with low toxic potential
ResolveMass Laboratories strictly follows USP <467> to make sure all product batches are tested using validated Headspace Gas Chromatography (HS-GC) methods, tailored to your sample type and required regulations.
FDA Expectations for Residual Solvent Testing in United States
The FDA expects pharmaceutical manufacturers to:
- Use validated analytical methods (e.g., HS-GC, HS-GC-MS)
- Provide complete ICH Q3C data on solvents used
- Maintain batch-level documentation
- Ensure testing at both drug substance and final product levels
At ResolveMass, our team has decades of combined experience in FDA-facing projects and submissions, including 483-response support, making sure your compliance is audit-ready.
Our Experience: Real Case Study from a U.S. API Manufacturer
In 2024, ResolveMass worked with a U.S.-based API manufacturer submitting a new drug application (NDA). The client faced an obstacle when FDA reviewers raised concerns about potential benzene contamination.
Case Details:
- Product: Small molecule API
- Initial concern: Trace benzene (Class 1 solvent) from an intermediate synthesis step
- Testing method: Headspace GC with Flame Ionization Detector (FID)
- LOD/LOQ achieved: 0.5 ppm / 1.0 ppm
- Result: Benzene was not detected
- Outcome: NDA was cleared without further review
This case highlights our ability to detect solvents at ultra-trace levels and meet FDA expectations using fully validated USP <467> methods.
Methodology We Use for Residual Solvent Testing in United States
At ResolveMass, we follow a three-phase strategy for residual solvent testing:
1. Sample Preparation
- Matrix-specific optimization (e.g., solid, semi-solid, liquid)
- Use of validated headspace conditions
2. Analysis
- HS-GC/FID or HS-GC/MS
- Detection limits as low as 0.1 ppm for critical Class 1 solvents
3. Reporting
- Full Certificate of Analysis (CoA)
- ICH Q3C classification and FDA submission-ready format
🔗 Learn how Canada regulations compare: Residual Solvent Testing in Canada – ResolveMass
Why Choose ResolveMass for Residual Solvent Testing in United States?
✅ Decade-long analytical expertise
✅ USP <467> and FDA-compliant reporting
✅ Fast turnaround: 3–5 business days
✅ Custom LOD/LOQ requests accepted
✅ Sample requirement: 100–500 mg
We’re proud to be a preferred analytical partner for top U.S. drug manufacturers, excipient suppliers, and biotech innovators.
Industries We Serve in the United States
- Pharmaceutical companies
- Contract manufacturing organizations (CMOs)
- Biotech startups
- Nutraceutical brands
- Cosmetic and personal care manufacturers
Residual solvent testing in United States is important not only for regulatory compliance but also for brand credibility and patient safety.
Residual Solvent Testing in United States for Import/Export Compliance
FDA checks on imported drug products are stricter than ever. If you manufacture or export APIs or formulations into the U.S., residual solvent testing is a must. ResolveMass offers import-compliance documentation accepted across:
- U.S. FDA
- Health Canada
- EMA (Europe)
- TGA (Australia)
Need Support for Your Next FDA Submission?
Whether you’re submitting an IND, ANDA, or NDA, residual solvent testing in United States is a mandatory component of your application. Our team will:
- Identify risk-prone solvents in your synthesis route
- Optimize method validation per ICH Q2(R1)
- Deliver FDA-ready reports with audit traceability
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FAQ
It is an analytical procedure used to detect and quantify trace amounts of solvents that may remain in drug substances or products after manufacturing.
USP <467> and FDA guidelines, supported by ICH Q3C and ICH Q2(R1) for method validation.
Class 1: Toxic solvents to avoid (e.g., benzene)
Class 2: Solvents with limited use (e.g., methanol)
Class 3: Low toxic potential solvents (e.g., ethanol)
Using Headspace Gas Chromatography (HS-GC), often with FID or MS detectors depending on sensitivity needs.
At ResolveMass, typical turnaround is 3–5 business days. Urgent testing is available.
Generally, 100–500 mg. Our team will guide you based on the matrix type.
Yes. We offer custom method development and validation per ICH and USP <467>.
Yes. Our reports are formatted for FDA submissions and include full compliance documentation.
Yes. We serve a wide range of industries including pharma, cosmetics, and wellness sectors.
ResolveMass offers regulatory-ready testing, industry-leading expertise, and highly responsive client support for complex solvent profiling.
Final Thoughts: Ensuring Compliance Through Trusted Analytical Expertise
In today’s competitive and tightly regulated environment, ensuring that your products meet the required limits for residual solvents is a must. Residual solvent testing in United States is more than a regulatory step—it’s a key part of your commitment to patient safety and product quality.
ResolveMass Laboratories Inc. stands as a trusted partner for GMP-compliant, USP <467> validated solvent testing tailored to your formulation and regulatory needs.
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