acceptable limit
- Guideline or reference source
- ICHM7 Assessment and control of dna reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk
- Definition
- Maximum acceptable concentration of an impurity in a drug substance or drug product derived from the acceptable intake and the daily dose of the drug.
- Related Term
- acceptable intake
- impurity
Send comments to info@celegence.com Please read disclaimer before using Qsauri.