Residual solvents are classified based on their potential health risks and environmental impact:
ICH Q3C (R6) Classification
1. Class 1: Known human carcinogens (e.g., benzene, carbon tetrachloride)
2. Class 2: Non-carcinogenic, but potentially toxic (e.g., acetone, ethyl acetate)
3. Class 3: Low-toxicity solvents (e.g., ethanol, isopropanol)
USP <467> Classification
1. Class 1: Solvents to be avoided
2. Class 2: Solvents to be limited
3. Class 3: Solvents with low toxic potential
Ph. Eur. 2.4.24 Classification
1. Class A: Solvents known to be carcinogenic
2. Class B: Solvents known to be toxic
3. Class C: Solvents with low toxic potential
FDA Classification
1. Class 1: High-risk solvents
2. Class 2: Moderate-risk solvents
3. Class 3: Low-risk solvents
Environmental Classification
1. Volatile Organic Compounds (VOCs)
2. Hazardous Air Pollutants (HAPs)
3. Priority Pollutants
Other Classifications
1. REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals)
2. GHS (Globally Harmonized System of Classification and Labeling of Chemicals)
Understanding these classifications helps ensure safe handling, use, and control of residual solvents.
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