Actual and potential impurities that are likely to arise during the synthesis and storage of a new drug substance, and during manufacturing and storage of a new drug product, should be assessed.
The impurity assessment is a two-stage process:
- Actual impurities that have been identified should be considered for their mutagenic potential.
- An assessment of potential impurities likely to be present in the final drug substance is carried out to determine whether further evaluation of their mutagenic potential is warranted.
The steps applies to synthetic impurities and degradation products.
When the impurities has been identified – Saxocon can provide the hazard assessment for the compounds.
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