Q3C (R5) Impurities: guideline for residual solvents

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