Class 1 Residual Solvents

Analytical testing dots Class 1 Residual Solvents

Residual solvents are separated into three classes based on risk assessment or their potential toxicity level. Class 1 solvents should be avoided in all pharmaceutical manufacturing because they have known human carcinogens or they have strongly suspected carcinogens and/or environmental hazards.

The following is a list residual solvents as well as their acceptable levels as adopted by the International Conference on Harmonization (ICH Q3C).

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Class 1 Residual Solvents List

Solvent Concentration limit (ppm)
Benzene  2
Carbon tetrachloride  4
1,2-Dichloroethane  5
1,1-Dichloroethene  8
1,1,1-Trichloroethane  1500

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