As one of the world’s leading chemical and pharmaceutical suppliers in the last decades, BOC Sciences provides impurity isolation and identification services for scientists and researchers who are devoted to drug development research. We now offer impurity removal, API purification, and product upgrade services through multiple drug analytical technology platforms.

Drug quality is related to the health and safety of drug users, so the impurities of listed drugs are more and more strictly controlled in many countries. In the process of drug development, liquid chromatography-mass spectrometry (HPLC-MS) is not only one of the commonly used techniques in drug impurity analysis, but also one of the effective means for qualitative and quantitative analysis of impurities that may be produced by drugs. With the continuous development of the pharmaceutical industry, HPLC-MS is also developing into one of the most important tools in the fields of life science, medicine, clinical, and chemical industries. BOC Sciences provides pharmaceutical impurity analysis services and can use various technologies such as HPLC to separate and regulate impurities in starting materials, intermediates, API and pharmaceutical products.

Analysis of impurities in natural products

Natural products often contain many kinds of chemical components, with complex structure and low content, and a considerable part of them have poor stability, so it is difficult to separate and identify them using conventional techniques. The analysis of this kind of sample by the HPLC-MS method is efficient, rapid and sensitive, and only requires simple pretreatment or derivation of the samples. The HPLC-MS method is especially suitable for the separation of low-content components which are easily changed or lost in the process of separation. Therefore, HPLC-MS plays an important role in the study of natural products.

Analysis of routine impurity

The structure of unknown impurities in drug research can be analyzed by high-performance liquid chromatography-mass spectrometry (HPLC-MS). The principal components and related impurities can be effectively separated by gradient elution. Through the analysis and summary of the liquid chromatography and mass spectrometry corresponding to the liquid chromatographic peak and impurity peak, the impurities in the sample can be inferred, and the impurities are taken as the main control object. The research provides a reference for drug production, process improvement and quality control.

Analysis of special impurities

In the quality control of some preparations with special raw material sources, the HPLC-MS hyphenated technology can better distinguish the correlation between impurities in the raw materials and impurities in the preparation, and provide references for process optimization and reasonable storage of the preparation. In some cases, due to the low content of impurities or the interference of other components, it may be difficult to analyze drug impurities directly by HPLC-MS. At this time, we should consider taking corresponding auxiliary measures such as LC-Q-TOF/MS, HPLC-ELSD/CAD, GC-MS to improve the accuracy and convenience of the analysis.

BOC Sciences’ Unique Technology

In addition to the conventional impurity separation and identification techniques, we also provide another method to remove small molecular impurities below six angstroms with a 100-fold throughput. The technology is based on a patented material with a well-defined six-angstrom porosity that can identify the product from impurities. In addition, the throughput of the chromatographic column can be increased by 100 times after further design. The experimental results show that through our new technology, the genotoxic impurity NDMA in drug products has been removed by more than 99% (from 2000 ppm to < 1 ppm), and the concentration has been reduced to less than the daily intake allowed by the FDA. At the same time, the yield of active drug ingredients remains more than 90% and is measured by following the GC method published by the FDA. The concentration can be reduced by repeating the separation process.

For more information about impurity isolation and identification, please visit the website: https://www.solutions.bocsci.com.

About BOC Sciences

The goal of BOC Sciences has always been to offer strategies and solutions for pharmaceutical companies so as to help them solve their most urgent and pressing drug R&D issues. With high ambitions, it offers one-stop integrated drug discovery and design services covering medicinal chemistry, drug testing, custom synthesis, analysis/purification, and formulation for scientists who are engaged in drug discovery and research.