Impurity Analysis
The production process of any API involves complex chemical and biological changes, which cannot avoid the generation of impurities. A variety of impurities such as API-related substances, residual organic solvents and inorganic impurities are generated, and their physical and chemical properties, contamination and potential for cross-contamination are key considerations regarding API quality, safety and efficacy. Investigation of impurities is one of the most important part in the API process. However, the study and control of impurities is a time, energy and money consuming process. Aiming to achieve the goal of obtaining the highest possible API purity, BOC Sciences analyze the levels of impurities in APIs as well as the physical, structural and behavioral properties of these impurities to help our customers determine the potential causes of variation.
Figure 1. The classification of impurities by the ICH. (Abdin, A. Y.; Yeboah, P. et al. 2020)
What is an impurity?
Any compound that is not part of the API is considered as impurity. Impurities may arise from reaction raw materials or reaction solvents, or from chemical reactions. Impurities can be divided as inorganic impurities and organic impurities. Among the inorganic impurities all originate from the reaction raw materials; while organic impurities include solvent residues and impurities generated in some reaction steps
Our Services
To make it easier and better for researchers, BOC Sciences provides impurity analysis service in a competitive fashion. We have provided a more efficient way to increase the number of new drugs, greatly shorten the R&D cycle, and reduce the development costs. Our team identifies impurities before they affect the quality, efficacy and safety of the drug
Impurity identification and separation process
a. Preparation and standardization of impurities
b. Preparation and standardization of API standard samples
c. Impurity studies and impurity profiling
d. Quality studies and stability testing
Metal impurity identification
- Inductively coupled plasma mass spectrometry (ICP-MS)
- Inductively coupled plasma optical emission spectrometry (ICP-OES)
- Graphite furnace atomic absorption spectrometry (GFAAS)
Figure 2. The Space of Information available for an impurity in a drug at a specific time. (Abdin, A. Y.; Yeboah, P. et al. 2020)
Impurity analysis
- Separation and monitoring of impurities in starting materials, intermediates, APIs and pharmaceuticals using various techniques
- Collection of complete 1D/2D NMR, LC-MS, EA, HRMS, IR, UV and other data
- Isolation and structural identification of API forced oxidative degradation products
- Rapid determination of crude materials, intermediates, APIs and synthetic impurities using quantitative NMR (QNMR)
- Preparation of professional application materials
- Detailed analysis and data preparation of impurities in API products in preparation for filing
Figure 3. Classification of Impurity. (Bhusnure, O. G. 2016)
Features of structure elucidation services
- Rapid structural profiling using LC/UV/MS to quickly investigate samples and obtain exact mass, purity and substructural information on relevant components in the sample.
- Ion mapping and NMR analysis for detailed structural studies
- MS ion mapping for detailed structural analysis to obtain complete 1D and 2D homo and heteronuclear NMR data to obtain detailed structural information such as attachment/modification sites
Why choose BOC Sciences?
Our dedicated CMC team has provided tailored solutions to our clients from engagement to launch. With many years of industry experience, we provide clients with the following:
- Comprehensive, integrated CMC services with a flexible service model that grows with your programs
- Knowledgeable industry experts who deliver scalable, actionable insights
- World-class facilities and equipment that remain at the forefront of the global pharmaceutical research, analytical and development standards
- Our comprehensive services support products at every stage of the product lifecycle, from early-stage discovery to full commercial cGMP manufacture
- A focus on risk management that is designed to ensure completion of your technical goals
BOC Sciences provides professional, rapid and high-quality services of impurity analysis at competitive prices for global customers. Personalized and customized services of impurity analysis can satisfy any innovative scientific study demands. Our clients have direct access to our staff and prompt feedback to their inquiries. If you are interested in our services, please contact us immediately!
Reference
- Abdin, A. Y.; Yeboah, P. et al. Chemical Impurities: An Epistemological Riddle with Serious Side Effects. International Journal of Environmental Research and Public Health. 2020. 17(3): 1030.
