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Cleaning Validation Glossary


Substances dissolving other substances

Solvents are substances that dissolve other substances. Cleaning agents used in the cleaning process are often solvents. Per PDA TR29, final rinse solvents for active ingredients, degradants, and cleaning agent should be analyzed as part of the cleaning process' performance parameters. ICH Q3C states that residal solvents are organic volatile chemicals that are used or produced in the production of drug substances or excipients and should be removed to the extent possible to meet product specifications.

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