Nudelman ChemTox
Consulting
Qualification of Non-Mutagenic Impurities
Drug Substances
This service focuses on evaluating impurities in active pharmaceutical ingredients (APIs) to ensure they meet safety and quality standards. Key activities include:
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Aligning assessments with the ICH Q3A(R2) guideline, including defining thresholds based on the maximum daily dose of the drug substance.
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Recommendation and coordination of qualification studies to demonstrate that impurities above identification thresholds do not pose safety concerns.
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Providing recommendations for impurity control strategies to support regulatory submissions.
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This service ensures the safety of APIs while facilitating regulatory approval by adhering to stringent impurity qualification standards.
Drug product
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Evaluating impurities according to limits defined in the ICH Q3B(R2) guideline, including reporting and qualification thresholds based on the maximum daily dose of the product.
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This service addresses impurities present in the final drug product, whether originating from the API, excipients, or the manufacturing process. Key activities include:
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Designing and coordinating in vitro and in vivo studies, to address impurities that exceed the ICH Q3B qualification threshold.
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By ensuring compliance with ICH Q3B guideline, this service supports the safety and efficacy of drug products while addressing regulatory expectations.