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Modeling the Impact of Excipients Selection on Nitrosamine Formation towards Risk Mitigation
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Background on Purging Factor Calculation for your Risk Assessment
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698
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Analysis of N-Nitrosodimethylamine (NDMA) in Pharmaceutical Products in the Presence of High Concentration N,N-dimethylformamide (DMF) -Pub
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375
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Synthesis of Nitroso Derivatives of Dihydropyridine Calcium Channel Blockers
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Addendum to ICH M7 on Risk Assessment and Control of N-Nitrosamine Impurities
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8
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📖 Drug Substance and Drug Product Workflows for Quality Risk Management for the Presence of Nitrosamines in Medicines-Pub
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May 27, 2025
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What if the answer you’re looking for is already here, with someone in this community?
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FDA Generic Drugs Forum - Bioequivalence Approaches
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Nitrosamines: Mass Spectrometry-Based Analytical Procedures Criterias
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