Lhasa Limited is delighted to announce the release of Mirabilis 4.2, providing members with advanced customisation options, and a more streamlined user experience. Mirabilis is a solution built in collaboration with industry and regulators and Lhasa continues to support our members and the wider scientific community in carrying out straightforward impurity risk assessments. The implementation of the new features, which are as a direct result of member feedback, underscores Lhasa’s commitment to meeting the evolving needs of the pharmaceutical industry.
Mirabilis provides an industry-standardised approach for calculating purge factors of potentially mutagenic impurities (PMIs). Using Mirabilis can help you to evaluate carry-over risk for PMIs in drug substance synthesis.
To aid in regulatory submission, Mirabilis allows you to create a report that includes the predicted purge calculation, scientific rationale and supporting evidence. The introduction of customizable reports in this release allows members to selectively choose specific sections and associated data. This feature makes it possible to tailor reports to meet unique needs, providing a more streamlined and efficient analysis of impurity predictions. A ‘Detailed Purge Calculation’ table has also been incorporated within the report, offering members a comprehensive overview of predicted purges for impurities at each stage.
Members can now benefit from the inclusion of the control limit in the summary table of the report. This addition provides a quick reference point for members, to ensure that impurity levels remain within predefined limits. A new option for the manual assignment of purge values (1, 3, or 10) via a dropdown menu is also now available, allowing members to override the solubility and volatility calculators, for enhanced control.
For more information about the full list of enhancements included in this release, or for more information about Mirabilis, please get in touch.