Vol. 8, Issue 1, Part A (2026)

Organic solvents are indispensable in pharmaceutical manufacturing, where they facilitate chemical reactions, extraction, and purification. However, small amounts of these solvents may remain in drug substances or finished dosage forms as process-related impurities. Such residues do not contribute to therapeutic performance and may pose safety concerns depending on their inherent toxicity and the extent of patient exposure. To address these risks, regulatory agencies require strict monitoring and control of residual solvent levels.

Recent progress in this field has been driven by improvements in analytical technologies, increased automation, and refinement of international regulatory frameworks. Gas chromatography-based techniques—particularly static headspace gas chromatography, GC coupled with mass spectrometry, and solid-phase microextraction—have enhanced detection capability, selectivity, and operational efficiency. At the same time, revisions to the ICH Q3C guideline have strengthened toxicological risk assessment through updated solvent classification and revised exposure limits. Parallel adoption of greener solvent alternatives and sustainable manufacturing practices has further reduced reliance on hazardous solvents. Together, these advancements reflect a shift toward science-based, risk-oriented solvent control supported by robust analytical strategies.