Residual solvents are residues from the synthesis of active pharmaceutical ingredients, intermediates or starting materials. In the manufacturing process, these often cannot be completely removed, but pose a health risk due to their sometimes high toxic potential. Therefore, it is necessary to control corresponding limit values in the end products in question.
These limits are specified by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
Based on their toxicity, residual solvents are divided into three classes with increasing hazard potential and thus increasing analytical effort.
Residual solvent classes
Class 1: Residual solvents to be avoided
Class 2: Residual solvents of limited use
Class 3: Residual solvents with low risk
GMP-compliant detection of residual solvents. Pharm. Eur. 10.0/2.4.24 incl.
- Quantitative determination
- Limit testing
GMP-compliant method validation for special cases incl.
- Method development
- Transfer validation
Reference Analytics Methods
For most residual solvents our HS-GC-MS allows accurate and reliable analysis in very low detection limits.
In addition, however, there are also very many special cases – do not hesitate to contact us if you have any questions.