Impurity and degradant control
Supporting your identification and control of impurities in Active Pharmaceutical Ingredients (APIs) and drug product
Identification and control of impurities and degradants in active pharmaceutical ingredients (APIs) and pharmaceutical drug products is a critical aspect of the drug development process when assessing chemical safety.
Mutagenic impurities of drug products can complicate formulation, lengthen the drug development timeline, and impact shelf life due to growth of degradation products.
Several regulations now call for greater reporting and control on impurities and degradants in drug substances at lower level based on the threshold of toxicological concern and daily dose.
Mirabilis provides an industry-standardised approach for calculating purge factors of potentially mutagenic impurities. Using Mirabilis can help you to evaluate carry-over risk for potentially mutagenic impurities in drug substance synthesis.
Manage your impurity risk
A risk assessment tool to assist with the management of your potential mutagenic impurities (PMIs), Mirabilis generates a reactivity purge factor for the impurities based on empirical data, and provides predictions for reactivity, solubility and volatility purges. Mirabilis can calculate the purge required to eliminate an impurity and determine the purge ratio, to identify if Option 4 is the best control strategy as per ICH M7.
Predict reactivity, solubility, and volatility purge factors
Reactivity predictions are provided by Mirabilis based on the actual reagents and conditions which are confirmed by the user. Mirabilis also includes a calculator for solubility purges which is applied for extractions and can help provide the additional supporting information for such purges. In addition, a volatility calculator is included to allow volatility purges to be applied based on the impurity’s boiling point as well as the operational temperature and pressure, or solvent being removed.
Align with industry and regulatory approach
Mirabilis provides an industry-standardised approach for calculating purge factors of potentially mutagenic impurities. To aid in regulatory submission, Mirabilis allows you to create a report that includes the predicted purge calculation, scientific rationale and supporting evidence. Mirabilis members also have the chance to interact and exchange knowledge and experiences at regular conferences promoted by Lhasa.
Zeneth identifies forced degradation pathways of organic compounds, which can help you to characterise structures of degradants observed in forced degradation studies quickly.
Identify and assess degradants
Using its comprehensive knowledge of degradation pathways, Zeneth can swiftly provide predictions for likely degradation products of drug compounds. In addition, drug-excipient interactions can be assessed to understand potential stability issues in the final formulated product.
Enable informed decision making
Zeneth can be used in exploratory formulation departments to identify potential degradation problems with a drug at an early stage in the drug development workflow. This early understanding can aid future decisions around experimental requirements as well as excipient selection.
Manage regulatory submission
After processing a drug compound through Zeneth, a range of filters can be applied to provide a results tree that can be compared to experimental findings. Using the customisable report feature in Zeneth, users can create reports suitable for regulatory submission.
The prediction and control of impurities and degradants in drug substances is a key requirement for a number of chemical safety assessments and regulations:
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