Impurities Identification and Characterization

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  • Published date: April 1, 2019
    • Shirley, New York, United States

Impurity profiling of a drug is an integral part to establish drug quality standards. According to the general guidelines stipulated by the International Conference to qualify the drug substance, the amount of acceptable level of each impurity should be less than 0.10%, respectively. In order to meet the stringent regulatory requirements, impurities should be identified. In recent years, the impurity profile of a drug substance has become more important for marketing approval and this work is done as part of a drug development process. We believe that development of a drug substance is incomplete without the identification of an impurity profile involved in the process. Thus, the studies that contain formation, identification, synthesis and characterization of impurities will be of immense help for pharmaceutical development teams.

Scientists at BOC Sciences are adept at the latest analytical methods of Impurities identification and characterization of drugs. We have the advanced analytical instruments and top experts in all analytical areas. We can provide rapid, reliable, safe method in impurities identification and characterization of drug detection, even if these drugs are low in content. We guarantee high quality standards and work closely with our customers. We provide impurity analysis services, including identification and characterization of impurities in the fields of organic synthesis and drug synthesis. The structures of these substances are showed in the figure below.

https://www.bocsci.com/solutions/impurities-identification-and-characterization.htm

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