About This Service
AnalytiLab provides ICH Q3C and USP <467> compliant residual solvent testing for APIs, drug products, and excipients. Using headspace GC-FID and GC-MS, we detect and quantify Class 1 (carcinogenic), Class 2 (non-genotoxic), and Class 3 (low toxic potential) solvents with high sensitivity and accuracy.
Key Information
Accredited by
What's Included
Instruments Used
GC-FID with Headspace Sampler
Primary method for residual solvents
GC-MS
Identification and confirmation of unknowns
Headspace Autosampler
Automated sample introduction
Static Headspace System
Volatile solvent analysis
Regulatory Standards
How We Work
Solvent Identification
Solvents used in synthesis identified; ICH Q3C class determined.
Method Selection
USP <467> method or validated in-house method selected.
Headspace GC Analysis
Samples analyzed by headspace GC-FID with certified reference standards.
Limit Comparison & Report
Results compared against ICH Q3C/USP <467> limits; compliance report issued.
Ready to Start Your Residual Solvent Testing?
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