Residual solvents classification, procedure for establishment of limits and determination of levels
Description
Residual solvents classification: -
Residual solvents: -
Organic solvents that are used in manufacturing process of the drug substances, excipients and drug product are called Residual solvents.
The residual solvents are not completely removed by practical manufacturing techniques.
Moreover, residual solvents affect the yield by reacting with the drug mixture components and somehow toxic to the intake, they must be identified, Quantified and evaluated.
Residual solvents are classified according to their Toxicity levels and Permitted Daily Exposure (PDE) and Risk assessment
