Question

In case of solvates the following are examples of Class I residual solvents that have been classified by the ICH.

• A. Benzene, carbon tetrachloride and 1, 2-dichloroethane
• B. Acetonitrile, cyclohexane and toluene
• C. Methanol and N,N-dimethylacetamide
• D. Acetic acid, acetone and ethanol

Answer 1

The Correct Option is A

To determine which examples of Class I residual solvents have been classified by the ICH, we need to understand what Class I solvents are. These solvents are known for their toxicity and environmental hazards; they should be avoided in pharmaceutical processes whenever possible. The International Council for Harmonisation (ICH) classifies these solvents as potentially carcerogenic.

The options provided are:

• Benzene, carbon tetrachloride and 1, 2-dichloroethane
• Acetonitrile, cyclohexane and toluene
• Methanol and N,N-dimethylacetamide
• Acetic acid, acetone and ethanol

Let's analyze each option:

1. Benzene, carbon tetrachloride and 1, 2-dichloroethane: All three chemicals are recognized as Class I solvents. Benzene is a known carcinogen. Carbon tetrachloride is toxic and suspected of causing cancer. 1,2-Dichloroethane is also known to be potentially carcinogenic. Thus, this option is correct.
2. Acetonitrile, cyclohexane, and toluene: These are not classified as Class I solvents. Instead, they are typically classified under Class II due to their lower toxicity than Class I solvents.
3. Methanol and N,N-dimethylacetamide: Methanol and N,N-Dimethylacetamide also do not fall under Class I. Methanol is considered a Class II solvent and N,N-Dimethylacetamide is more harmful but not Class I.
4. Acetic acid, acetone, and ethanol: Each of these solvents is relatively low-risk and often falls under Class III due to low toxicity compared to Class I solvents.

Based on this thorough evaluation, the correct answer is:

Benzene, carbon tetrachloride, and 1, 2-dichloroethane