Scientifically robust software providing an industry-standardised approach for calculating purge factors of potentially mutagenic impurities.
- Mirabilis is a risk assessment tool to assist with the management of your mutagenic impurities.
- Mirabilis can be used to satisfy ICH M7 Control Option 4 by producing an estimated purge factor for removal of an impurity by a synthetic process.
- Mirabilis is built on expert knowledge and is semi-automated to improve the efficiency of purge analysis.
- Lhasa Limited is part of the Mirabilis Consortium, which sponsors and guides the development of Mirabilis.
Why Do You Need Mirabilis?
ICH M7 Control Option 41 outlines that “a control strategy that relies on process controls in lieu of analytical testing can be appropriate if the process chemistry and process parameters that impact levels of mutagenic impurities are understood and the risk of an impurity residing in the final drug substance above the acceptable limit is determined to be negligible”. Importantly, it goes on to clarify that “in many cases, justification of this control approach based on scientific principles alone is sufficient”.
Analytical testing can be replaced by a risk assessment if:
- The impact of the synthetic process on an impurity is confidently understood and
- The risk of an impurity residing in the final drug product above an acceptable limit is determined to be negligible
The guideline states that the “risk assessment can be based on physicochemical properties and process factors that influence the fate and purge of an impurity including chemical reactivity, solubility, volatility, ionizability and any physical process steps designed to remove impurities.”
Mirabilis can be used to help satisfy Option 4 by producing estimated reactivity, solubility and volatility purge factors for removal of the impurity by a synthetic process. As such, Mirabilis can reduce the need to set up costly and time-consuming analytical methods for the measurement of impurities that are unlikely to be present in the final drug product.
To see a list of our current member organisations, click here.
- Teasdale et al. (2010) ‘A Tool for the Semiquantitative Assessment of Potentially Genotoxic Impurity (PGI) Carryover into API Using Physicochemical Parameters and Process Conditions’, Organic Process Research & Development, vol. 14, pp 943-945. http://dx.doi.org/10.1021/op100071n
- Teasdale et al. (2013) ‘Risk Assessment of Genotoxic Impurities in New Chemical Entities: Strategies To Demonstrate Control’, Organic Process Research & Development, vol. 17, pp 221-230. http://dx.doi.org/10.1021/op300268u