purge factor
- Guideline or reference source
- ICHM7 Assessment and control of dna reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk
- Definition
- Purge reflects the ability of a process to reduce the level of an impurity, and the purge factor is defined as the level of an impurity at an upstream point in a process divided by the level of an impurity at a downstream point in a process. Purge factors may be measured or predicted.
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