Table of contents
Part I ........................................................................................................... 4
Impurities: Residual solvents - Parent guideline .................................................. 4
1. Introduction ............................................................................................. 4
2. Scope of the guideline .............................................................................. 4
3. General principles .................................................................................... 5
3.1. Classification of residual solvents by risk assessment .................................... 5
3.2. Methods for establishing exposure limits ..................................................... 5
3.3. Options for describing limits of class 2 solvents ............................................ 6
3.4. Analytical procedures ................................................................................ 7
3.5. Reporting levels of residual solvents ........................................................... 7
4. Limits of residual solvents ....................................................................... 8
4.1. Solvents to be avoided .............................................................................. 8
4.2. Solvents to be limited ............................................................................... 8
4.3. Solvents with low toxic potential ................................................................ 9
4.4. Solvents for which no adequate toxicological data was found ....................... 10
Glossary ..................................................................................................... 11
Appendix 1: List of solvents included in the guideline................................ 12
Appendix 2: Additional background ........................................................... 16
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