Purity Studies

1. Purity Studies Purity studies is a method that depends on properties and chemical reaction to analyze the purity of substance, since the presence of impurities in drug substance is extremely critical issue and can have a significant impact on the quality and safety of drug. The International Conference of Harmonization (ICH) guidelines indicate that unknown impurities at or above 0.10% in the drug substance depending on the maximum daily dosage, should be characterized. It is the most concerning task in modern pharmaceutical analysis to manufacture high quality drug. According to the clinical trials of drugs, the presence of small amounts (0.01-0.1%) of a highly mutagenic impurity produced positive mutagenicity results, therefore, the need to assess for chemical purity of drug components before the drug is formally put into use. Purity study plays an important role in the drug researches. Scientists at BOC Sciences are adept at purity studies of drugs. We have the advanced analytical instruments and top experts in all analytical areas. We can provide rapid, reliable, safe and clean method in purity studies of drug, even if that is tiny amounts of a substance. We guarantee high quality standards and work closely with our customers. BOC Sciences is pleased to offer purity studies services, including: Purity studies in the organic synthetic field Organic synthetic products can be found everywhere in our lives. Radezolid is considered to be an organic synthetic product, which plays a vital role in drug research. The purity has been studied by the method of FT-IR, Raman, NMR and ECD techniques with the support of the DFT theory. The Chemical structure of radezolid is showed in Fig 1. We believe that development of organic synthesis products is incomplete without the identification of an impurity profile involved in

2. the process. In our study we explored the synthesis, identification and characterization of impurities found in the synthesis of organic. This study will be of immense help for pharmaceutical development teams to understand the potential impurities in organic synthesis and thereby obtain the pure compound. Fig. 1. Chemical structure of radezolid Purity studies in the pharmaceutical research field 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. Of course, it is a challenging work for the development team to identify the impurities formed in very small quantities in a drug substance. In order to reduce costs, the impurities should be synthesized by the development team. Wogonin has been synthesized chemically as a pharmaceutical agent. Although its pharmacological activities have been well demonstrated, the impurity profile of this synthesized medicinal compound is still not fully understood. During the analysis of the laboratory batches of wogonin crude, an unknown related impurity with its area percentage ranging around 0.1% was detected. Therefore, a selective and specific analytical method for their guarantee needs to be developed and validated. From the analytical point of view, high performance liquid chromatography (HPLC) coupled with different types of detectors, including conventional ultraviolet (UV), electrochemical, mass spectrometer (MS) or tandem mass spectrometer (MS/MS) have been reported for determination of wogonin in herbs, extractions, dietary supplements, bio-fluids and animal tissues.

3. BOC Sciences is proud to provide you with high-quality Purity Studies Method. Glad to hear your comments and look forward to cooperating with you. Reference 1. Katarzyna Michalska, Ewa Gruba. Application of spectroscopic methods (FT-IR, Raman, ECD and NMR) in studies of identification and optical purity of radezolid [J]. Molecular and Biomolecular Spectroscopy, 2017, (183). https://www.bocsci.com/solutions/purity-studies.htm