Residual solvent: difference between revisions
Diff·revision 1 → 2·08:57, 8 Sep 2024
Difference between revision 1 and revision 2 of Residual solvent. 9 lines changed; the page grew by 737 bytes.
| Revision 1 — 09:00, 2 Sep 2024 AAA_Analyst (talk) new article: analytical method, expansion welcome 1,225 bytes +1,225 | Revision 2 — 08:57, 8 Sep 2024 NewLabNell (talk) ce per PP:MOS 1,962 bytes +737 | ||
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| 10 | In peptide manufacture the solvents of interest are those used in [[Solid-phase peptide synthesis|synthesis]], cleavage and purification — dimethylformamide, dichloromethane, acetonitrile, methanol, trifluoroacetic acid and diethyl ether among them. Several fall in Class 2 and are limited accordingly.{{r|usp467}} | 10 | In peptide manufacture the solvents of interest are those used in [[Solid-phase peptide synthesis|synthesis]], cleavage and purification — dimethylformamide, dichloromethane, acetonitrile, methanol, trifluoroacetic acid and diethyl ether among them. Several fall in Class 2 and are limited accordingly.{{r|usp467}} |
| 11 | 11 | ||
| + | 12 | == Classes and limits == | |
| + | 13 | | Class | Basis | Examples relevant to peptides | Control | | |
| + | 14 | |---|---|---|---| | |
| + | 15 | | 1 | Known or suspected human carcinogen | Benzene, carbon tetrachloride | To be avoided | | |
| + | 16 | | 2 | Non-genotoxic animal carcinogen or other toxicity | Dichloromethane, methanol, acetonitrile, N,N-dimethylformamide | Limited by specified concentration | | |
| + | 17 | | 3 | Low toxic potential | Acetic acid, ethanol, diethyl ether, acetone | Generally limited at 0.5% | | |
| + | 18 | ||
| + | 19 | Limits for Class 2 solvents are derived from a permitted daily exposure and a maximum daily dose, so a concentration limit depends on how much substance is administered. A concentration expressed without reference to that basis cannot be assessed against a limit.{{r|ich_q3c}} | |
| + | 20 | ||
| 12 | == References == | 21 | == References == |
| 13 | {{reflist}} | 22 | {{reflist}} |