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Molecular characterization of a refers to the process of identifying and analyzing the molecular structure and composition of a substance, typically to understand its properties, functions, and potential applications.
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Entities involved in the development, production, or distribution of biological products, pharmaceuticals, or certain regulated substances are typically required to file molecular characterization.
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The purpose of molecular characterization is to ensure the safety, efficacy, and quality of biological products and pharmaceuticals, as well as to facilitate compliance with regulatory standards.
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Reported information typically includes data on molecular structure, composition, functional attributes, methods of analysis, and any relevant safety assessments.
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