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The Importance and Purpose of Impurity Research

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The Importance of Impurity Research

Impurity standard is the key quality attributes of drugs (APIs and preparations), an important part of drug research (quality, safety), and the focus of drug evaluation.

Impurity research is distributed in all aspects of drug R&D, such as materials used, intermediates, APIs, pre-prescription research-quality assessment of raw and excipient materials, formulation design and optimization, preparation process, stability, compatibility, packaging integrity, etc.

Impurity research runs through the entire life cycle of drugs, such as development and optimization of process, design and optimization of prescription, safety, quality control of raw materials and excipients, production process control, production quality inspection, post-marketing stability, retrospective analysis of product quality, and change management, etc.

Purpose of Impurity Research

The purpose of impurity research is to understand the process of drug quality risk through the research on impurities in the materials used and final products (API, preparations), as well as on the generation, transformation or removal process of impurities in the production process, so as to optimize, confirm prescriptions, process, packaging, and storage conditions provide supporting information, and based on this, establish a drug quality process management plan and impurity control strategy——reveal product quality, understand product quality risks, and realize risk management of impurities throughout the process.

TOREF specializes in providing pharmaceutical reference standards/ impurity standards, high-purity organic reagents, inorganic reagents, biochemical reagents, analytical reagents, metal organic catalysts, proficiency testing and laboratory instrument consumables, etc., covering pharmaceutical, food, chemical industry, toys, electronic chemistry, minerals, aviation textiles, agriculture, wineries, health care products, analysis/ testing laboratories and other industries. At present, Toref has served more than 8,000 end customers and more than 2,000 channel distributors.