Diltiazem impurities are trace compounds that may be present in diltiazem drug formulations. These can arise from various sources, such as raw materials, synthesis processes, degradation, or storage. Regulatory bodies, like the FDA or ICH (International Council for Harmonisation), require monitoring of impurities to ensure drug safety and efficacy. Types of Diltiazem Impurities:Process-related impurities: These are formed during the synthesis of diltiazem and can include by-products, unreacted starting materials, or intermediates. Degradation products: These impurities can form during the storage or shelf life of the drug due to environmental factors like light, heat, or moisture. Residual solvents: Some impurities may come from solvents used in the manufacturing process that haven't been fully removed. Read More :https://www.allmpus.com/Diltiazem-EP-Impurity-E
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