ICH Q3C (R8) establishes the international framework for residual solvent classification and permitted daily exposure limits recognized by FDA, EMA, and PMDA. Our headspace GC/FID method delivers quantitative results with direct comparison to ICH Q3C concentration limits for pharmaceutical APIs, excipients, and finished drug products.
ICH Q3C is the global harmonized standard. USP <467> aligns to ICH Q3C for most solvents but differs in procedure details. Products registered in EU or Japan need ICH Q3C framing; US-only products typically reference USP <467>.
ICH Q3C is recognized by FDA (USA), EMA (EU), PMDA (Japan), and Health Canada. Products registered in multiple markets benefit from ICH-formatted reporting.
Manufacturing solvents used in multi-step API synthesis accumulate across process steps. ICH Q3C Class 1 solvents (benzene, 1,2-dichloroethane) require individual justification.
Chemistry, Manufacturing & Controls sections of INDs and NDAs must include residual solvent data formatted per ICH Q3C guidelines for international submissions.
Botanical extraction solvents — hexane (Class 2), ethanol (Class 3), CO₂ (not classified) — must be characterized per ICH Q3C when the extract is used in a drug product.
ICH Q3C Option 1 allows excipients to be qualified individually. Excipient suppliers providing ICH-formatted COA reduce the testing burden on their drug product customers.
Downstream purification of biologics and fermentation products using organic solvents must meet ICH Q3C limits before product can be used in clinical or commercial supply.
Common solvents across all three ICH classes:
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