What do you mean by residual solvent? : Pharmaceutical Guidelines

What do you mean by residual solvent?

Interview Question #053
Residual solvents are the traces of the solvents left during the manufacturing of drug substances or active pharmaceutical ingredients and excipients. The solvents those are used during the manufacturing process are not completely removed during the manufacturing.
Some common residual solvents are:
Acetonitrile
Chlorobenzene
Chloroform
Cyclohexane
1,2-Dichloroethene
1,2-Dimethoxyethane
N,N-Dimethylacetamide
N,N-Dimethylformamide
1,4-Dioxane
2-Ethoxyethanol
Ethylene glycol
Formamide
Hexane
Methanol
2-Methoxyethanol
Methylbutylketone
Methylcyclohexane
Methylene chloride
N-Methylpyrrolidone
Nitromethan



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