Impurities Identification and Characterization

Impurities Identification and Characterization

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.

Impurities Identification and CharacterizationFig 1. The structures of cefpiramide and tylosin1

BOC Sciences is pleased to offer Impurities identification and characterization services, including:

Impurities analysis in organic synthesis field

Impurities are inevitably formed in process of synthesizing final organic substance, including unreacted starting materials, by-products, intermediates, and degradation products. It is essential to carry out identification and structural elucidation of potential impurities in organic synthesis process. The combination of a trap-free two-dimensional liquid chromatography and ion trap/time-of-flight mass spectrometry is used for separation and characterization of impurities and isomers in cefpiramide. By using the technique of liquid chromatography coupled to high resolution ion trap/time-of-flight mass spectrometry, the molecular formula of a parent compound and its associated fragment ions can be deduced, which provide important information for solving complex structural problems.

Spectral analysis method is widely used in the pharmaceutical industry for applications such as the identification of potential drug candidates in pharmacological screens, the identification of impurities and degradation products obtained during clinical development. Tylosin is a macrolide antibiotic produced by Streptomyces fradiae. It is a medium spectrum antibiotic used in veterinary medicine for the treatment of infections caused by most Grampositive bacteria, mycoplasmas, some Gram-negative bacteria and Chlamydia. It is also used as a feed additive to promote livestock growth. A stringent control of the quality of veterinary medicines is required to ensure the safety of animals when they are used in food production. So, these drugs must also comply with regulatory guidelines related to quality, safety and efficacy. Content determination, identification of the unknown impurities and determination of appropriate limits for them are important parameters that help to evaluate the quality of a drug.

BOC Sciences is proud to provide you high-quality of impurities identification and characterization services. Glad to hear your comments and look forward to cooperate with you.


  1. Wang, J. and Xu, Y. (2017) ‘Application of a trap-free two-dimensional liquid chromatography combined with ion trap/time-of-flight mass spectrometry for separation and characterization of impurities and isomers in cefpiramide’, Analytica Chimica Acta, (992).
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