New York, USA – May 28, 2021 – Whether in the development of new drugs or the consistency evaluation process of generic drugs, impurities have become a key quality attribute of drugs. The research and control of impurities is an important link in the research and development of new drugs and generic drugs.
BOC Sciences recently updated its product list of pharmaceutical impurity reference standards to better serve pharmaceutical companies, scientific research units, testing institutions and universities.
Drug research and development has risks such as time-consuming, high cost, and low success rate. It involves processes such as drug discovery, preclinical research, clinical trials, application for registration, and marketing. Unidentified toxic impurities are harmful to health. Impurities in active pharmaceutical ingredients may come from the synthesis process or raw materials, intermediates, solvents, catalysts, and by-products. Impurities in active pharmaceutical ingredients can significantly change the properties of the drug. The content of various impurities in the active pharmaceutical ingredients determines the safety of the final finished drug. The level of impurities in medicines is a few percent, a few thousandths, or even lower. A medicine often contains several to dozens of impurities. Therefore, it is very difficult to characterize and quantify impurities in drugs.
Pharmaceutical impurity reference standards are standard substances that can be used for drug identification, inspection, content determination and calibration of the performance of verification instruments. They are special measurement tools used to check the quality of medicines, as well as a benchmark for measuring the quality of medicines, which will directly affect the accuracy and reproducibility of the test results. The location and quantification of impurities and the determination of instrument response factors require impurity reference substances. During the registration process, accurate identification and quantification of impurities are essential for documentation.
Using pharmaceutical impurity reference standards can reduce the loss caused by experimental errors, obtain high-quality research results in a short time, and shorten the time to market for drugs.
For more information about pharmaceutical impurity reference standards, please visit the website: https://www.bocsci.com/products/impurities-8.html.
About BOC Sciences
BOC Sciences excels in the impurity standards industry. The company’s impurity standard products have complete and reliable data, and the production and testing of its products are in compliance with cGMPs. It has many years of rich experience, an excellent R&D team, and unique development and analysis methods for impurity research. BOC Sciences has produced thousands of pharmaceutical impurities, degradants, metabolites of active pharmaceutical ingredients, and excipients in accordance with the guidelines described in the International Pharmacopeia monographs. And many impurities produced by this company can be applied in drug development, thus fully assisting the scientific research and development of pharmaceutical companies.