Nudelman ChemTox
Consulting
Qualification of Residual Solvents
This service ensures that residual solvents used during drug manufacturing are controlled within acceptable limits. Key aspects include classifying solvents based on their potential risks, as defined by ICH Q3C guidelines:
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Class 1 (toxic solvents): Must be avoided or strictly limited.
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Class 2 (potentially harmful solvents): Controlled to meet PDE (Permitted Daily Exposure) levels.
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Class 3 (low-toxicity solvents): Minimized as needed.
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For solvents not listed in the ICH Q3C guideline, read-across can be performed from structurally similar compounds.
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Other scientific justifications are available to qualify residual solvents at levels above the ICH Q3C limits, including the use of duration of treatment, route of administration, etc.
This service ensures compliance with safety thresholds while supporting high-quality drug development and regulatory submissions.