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Non-mutagenic impurities

Non-mutagenic impurities

Supporting the assessment and control of your non-mutagenic impurities

Assessment and control of non-mutagenic impurities

If an impurity is known to be non-mutagenic or non-carcinogenic, impurity levels – both in the API and drug product – may still need to be assessed and controlled, to demonstrate that the level of impurity present is safe for human exposure.

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Why choose Consult Lhasa?

Consult Lhasa provide expert non-mutagenic impurity risk assessments, built on Lhasa Limited science, that can be trusted by industry and regulatory authorities.

If you need assistance with your non-mutagenic impurity risk assessment, Consult Lhasa.

How can our experts help you to assess
non-mutagenic impurities?

Do you need help establishing safe limits for your non-genotoxic impurities (NGIs)?
When a non-genotoxic impurity (NGI) is present above the qualification threshold, an impurity qualification becomes necessary. We can provide a weight of evidence assessment to determine a safe limit for your NGI.

Does your process involve a residual solvent not included in ICH Q3C?
If a solvent is not included within the ICH Q3C guidelines, an independent calculation is required to determine an acceptable intake. If relevant and robust data exists, we can perform a permitted daily exposure (PDE) risk assessment to establish an acceptable limit for your residual solvent.

What if there is insufficient data for your solvent, not included in ICH Q3C?
In cases where high-quality data for your residual solvent is unavailable, the correct analogue – or class of analogues – needs to be identified. Where possible, we will provide appropriate read-across analogues and utilise the anologue/s to establish an acceptable intake (AI) for your residual solvent.

Do you need help evaluating the level of elemental impurities in your final drug product?
Elemental impurities (EIs) can originate from several sources and need to be controlled to a safe limit. It is important to evaluate each source to understand its contribution to overall EI levels in the final drug product. We can help you to assess the risk of EIs in your final drug product, relative to the permitted daily exposure (PDE), in line with the ICH Q3D guidance. If necessary, based on the risk assessment outcome, we can propose a control strategy.

We provide regulatory support

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For qualification of new drug substances produced by chemical synthesis.
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For qualification of impurities in new drug substances produced by chemical syntheses.
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For classifying solvents into one of three classifications, and associating safe limits.
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For assessing and controlling elemental impurities in the drug product, using a risk-based control strategy.

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If you are interested in discovering how Consult Lhasa could improve your non-mutagenic impurities risk assessments, get in touch.