As you may be aware, the US Food and Drug Administration (FDA), the European Medicines Agencies (EMA), and Health Canada have recently released a major update on N-nitrosamine impurities in human medicinal products supporting the categorical prediction of N-nitrosamine potency. The new approach is referred to as the Carcinogenic Potency Categorization Approach (CPCA) and is suitable for creating submissions with recommended acceptable intake (AI) based on the potency category derived from the N-nitrosamine’s structure.
A new version of the Leadscope Model Applier™ solution has now been released to calculate the potency category and associated AI limit based on the regulatory-accepted CPCA decision tree. The tool encodes the procedures and chemistry described in “Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs) – Guidance for Industry”1 such that an analysis is performed in a consistent manner. The implementation of the CPCA decision removes any manual effort in deriving AI limits from the N-nitrosamine’s structure.
Please contact info@instem.com if you would like to discuss this in more detail.
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