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Many organic solvents are used in pharmaceutical engineering, some of which are toxic or environmentally harmful and can be very difficult to remove. The crystallization process involved in the final purification step of most drugs captures some of the solvent that affects the quality of the drug as an impurity in the drug. Based on the potential risks of residual solvents to human health, the ICH guidelines classify them into three categories:
Class 1: Solvents to be avoided (Table 1)
Known human carcinogens, strongly suspected human carcinogens, and environmental hazards.
Class 2: Solvents to be limited
Non-genotoxic animal carcinogens or possible causative agents of other irreversible toxicity such as neurotoxicity or teratogenicity. Solvents suspected of other significant but reversible toxicities.
Class 3: Solvents with low toxic potential
Solvents with low toxic potential to man; no health-based exposure limit is needed. Class 3 solvents have PDEs of 50 mg or more per day.
Residual solvent limits are regulated by ICH, USP, and EP, and residual solvents in pharmaceutical manufacturing, purification, and finished products should be tested to control residual solvent content throughout the process. Alfa Chemistry's experts have extensive experience in residual solvent analysis, providing direct injection gas chromatography, headspace chromatography and other methods to support your compliance testing while developing customized inspection services. We support the quantitative and qualitative detection of all classes of residual solvents. Please feel free to contact us if you have any questions.
Table 1. Solvents that should be avoided in Pharmaceutical Products – ICH Q3C