April 2022
Real CMC Tips and Insights

published 2 May 2022

Since the beginning of July 2020, we have published weekly Regulatory tips and insights from our Regulatory experts on our Real Regulatory LinkedIn page, as a service to our followers. The tips we published in April 2022 are collected here, for convenience. Make sure you follow  Real Regulatory Ltd and Real CMC for regulatory news, reports and hints.

Class 2 residual solvents

The easiest way to know if your formulation is safe and approvable with regard to Class 2 residual solvents (solvents with known toxic potential) is to make sure each component meets the ICH Q3C Option 1 limit for each solvent. However, remember that Option 2 is also a valid approach when individual components do not meet Option 1 limits: you can use the permitted daily exposure for the solvent together with the maximum daily dose of the product to calculate an acceptable limit for the solvent in your medicinal product.

Use of surfactant in dissolution media

Dissolution media containing surfactant are often challenged by European assessors. Use surfactant at the lowest possible concentration, and only if absolutely necessary to achieve adequate release of poorly soluble drug substances. Be prepared with strong justification for the type and amount of surfactant used and with proof that the discriminatory power of the dissolution test remains adequate.


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