Residual solvent (revision 1)
Old revision·09:00, 2 Sep 2024·AAA_Analyst
This is an old revision of this page, as it stood at 09:00, 2 Sep 2024, saved by AAA_Analyst with the summary new article: analytical method, expansion welcome. It may differ substantially from the current revision, and any error it contains may since have been corrected.
| Residual solvent | |
|---|---|
| Governing guidance | ICH Q3C; USP <467> |
| Determined by | Headspace gas chromatography |
| Classes | Class 1 avoid; Class 2 limit; Class 3 low toxicity |
| Topic infobox · conventions | |
Residual solvents are organic volatile chemicals used or produced in manufacture that remain in the finished substance. They are classified by toxicity: Class 1 solvents are to be avoided, Class 2 are limited to specified concentrations, and Class 3 are regarded as low-risk and controlled at a general limit.[1]
In peptide manufacture the solvents of interest are those used in synthesis, cleavage and purification — dimethylformamide, dichloromethane, acetonitrile, methanol, trifluoroacetic acid and diethyl ether among them. Several fall in Class 2 and are limited accordingly.[2]
References
Categories: