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What is Drug Impurity Custom Synthesis?

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The technology is difficult, there are many kinds of impurities, and it is labor-intensive and time-consuming. Each drug generally has a few to a dozen impurities, and each pharmaceutical company has several to dozens of drugs that need to study impurities. Such a large number of impurity reference substances are prepared in the market demand, which is difficult for the technical staff of existing pharmaceutical companies. On the other hand, some kinds of impurities, due to the extremely small amount of milligrams at a time, have a backlog of remaining stocks and have no market.

Impurity custom synthesis has become one of the key concerns of drug regulatory agencies at home and abroad because of its possible impact on drug quality, safety and effectiveness. With the expansion of the export scale of China’s pharmaceutical products, it has become a topic of common concern for domestic pharmaceutical manufacturers to understand the drug impurity control requirements of foreign regulatory markets and strengthen the analysis and control of drug impurities.

  1. Use various techniques such as HPLC to separate and supervise impurities in starting materials, intermediates, APIs and drug products
  2. Collect complete 1D/2D NMR, LCMS, EA, HRMS, IR, UV and other data, and identify the structure of the separated impurities
  3. Separation and structure identification of forced oxidation degradation products of API
  4. Using quantitative NMR (QNMR) to quickly determine the content of crude materials, intermediates, API and synthetic impurities
  5. Prepare professional application materials

TOREF specializes in providing pharmaceutical 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.